CN112105853B

CN112105853B - Rotary valve

Info

Publication number: CN112105853B
Application number: CN201980026076.2A
Authority: CN
Inventors: 赛义德·安德什曼德; 托马斯·H·考利三世; 约翰·狄克逊
Original assignee: SlipChip Corp
Current assignee: Talis Biomedical Corp
Priority date: 2018-02-15
Filing date: 2019-02-15
Publication date: 2022-11-04
Anticipated expiration: 2039-02-15
Also published as: US20210116049A1; US20190249799A1; SG11202007359XA; AU2019227513A1; EP3752756A2; US10527192B2; WO2019168691A2; WO2019168691A3; IL276366B2; EP3752756A4; CA3089884A1; US11009150B2; IL276366B; CN112105853A; US20200182379A1; US11920700B2; JP2023169312A; JP2021514454A; JP7354157B2; IL276366A

Abstract

Rotary valves and methods of use, manufacture, and storage thereof are provided herein. The rotary valve includes a rotor and a stator that are biased toward each other to form a fluid-tight seal. In some embodiments, the rotor includes an integrated flow path that contains a porous solid support. Typically, the interface between the rotor and stator is fluid-tight using a gasket. Some embodiments of the rotary valve include a displaceable spacer to prevent a sealing gasket from sealing against at least one of the rotor and the stator prior to operation, wherein the sealing gasket seals the rotor and the stator together in a fluid tight manner when the spacer is displaced.

Description

Rotary valve

Cross Reference to Related Applications

The present application claims the benefit of U.S. patent application No. 15/898,064 entitled "ROTARY VALVE," filed on 15/2/2018, which is incorporated herein by reference in its entirety.

Statement regarding federally sponsored research or development

The invention was made with government support under contract number HR0011-11-2-0006 awarded by the department of Defense (DARPA). The government has certain rights in the invention.

Technical Field

The present invention relates to the field of rotary valves, for example for directing fluid flow in microfluidic and diagnostic devices.

Background

Valve-related laboratory or other diagnostic systems that use microfluidic components for real-time analysis of biological samples have great potential for use in a wide range of scientific research and diagnostic applications. Critical to the functioning of such systems is the method for directing the fluid to the correct sections of the device, in particular the microfluidic device.

The devices and methods described herein provide efficient ways to deliver fluids and/or separate one or more analytes therefrom. Such devices may be used to mix or meter fluids to perform, for example, chemical or biochemical purification, synthesis, and/or analysis. The devices of the invention may be used to evaluate a sample to determine whether a particular analyte, such as an organism, is present in the sample. Fluidic devices can be used to provide positive or negative assay results. For example, such devices may also be used to determine the concentration of an analyte or other characteristic of an analyte in a sample.

Fluidic devices are also used in bioassays in particular. The device may be used to capture an analyte from a solution, for example by filtration. Such capture may include concentrating the analyte in solution by passing the analyte through a porous solid support, selective matrix or membrane. The selective element in turn restricts the movement of the analyte away from the selective element without restricting the movement of the remaining solution. One practical application of capturing analytes is to concentrate nucleic acids by filtration into a volume suitable for an amplification reaction. In this case, even analytes with a small initial concentration can be captured from the solution and thereby concentrated. The single-shaft actuated valve apparatus reduces the cost and complexity of the instrument compared to conventional prior art valves. Furthermore, integrating zero, one or more flow passages and/or porous solid supports in the rotor reduces the requirements on the flow control layout and simplifies the design of the overall device compared to conventional existing valves.

Additional fluidic devices with moving parts may be structurally plagued by storage. For example, flexible materials that are compressed over time during storage or transportation (e.g., gaskets) may deform and/or may experience a loss of elasticity. Further long term storage under compression results in the flexible material adhering to the compression surface. Such conditions can negatively impact the operability of the valve (e.g., the containment, routing, and/or delivery of fluid therethrough by the valve). The sticking of the gasket can impede the movement of the valve, requiring a significant force to actuate the valve, or in some cases, the valve can jam and render it inoperable. The devices and methods of the present invention include a storage configuration in which a displaceable spacer holds the rotor away from the stator until the device is activated. In this way, the storage configuration avoids the problems of compression set and valve degradation associated with storage under pressure. The valve of the present invention thus reduces the need for gasket elastomer sealing surfaces, thereby enabling higher pressure ratings and longer operating and shelf life than conventional prior art valves.

SUMMARY

Rotary valves and methods of using, making, and storing the devices are provided herein. The valve device may comprise a rotor connected to a stator, and the rotor comprises a rotor valve face (rotor valve face) and a flow passage comprising a porous solid support (porous solid support). Versions of the valve apparatus include a displaceable spacer for preventing a sealing gasket from sealing against at least one of the rotor and the stator, wherein the sealing gasket seals the rotor and the stator together in a fluid tight manner when the spacer is displaced.

In one aspect, the present invention provides a rotary valve 00 comprising (a) a stator 50, the stator 50 comprising a stator face 52 and a plurality of passages 54, each passage comprising a port 53 at the stator face; (b) A rotor 10, the rotor 10 being operatively connected to the stator and comprising an axis of rotation 16, a rotor valve face 12 and a flow path 40 having an inlet 41 and an outlet 42 at the rotor valve face, wherein the flow path comprises a porous solid support 45; and (c) a retaining element 90, the retaining element 90 biasing the stator and rotor together at the rotor-stator interface 02 to form a fluid-tight seal.

In a preferred embodiment, the cross-section of the flow passage 40 is not concentric with the axis of rotation 16. In certain embodiments, the rotor valve face 12 includes a gasket 80 inserted at the rotor-stator interface 02. Such a seal 80 may include a hole 83 therethrough and may be laterally constrained by the arcuate track 70 on the stator. Alternatively, the stator face 52 may include a seal 80 inserted at the rotor-stator interface 02.

In some embodiments, the rotor valve face includes a fluidic connector 86, wherein in the first rotor position, the first port 53a of the stator is fluidly connected to the second port 53b of the stator via the fluidic connector 86. The rotary valve may also include a second rotor position in which the third port 53c is fluidly connected to the fourth port 53d via the fluidic connector 86. The stator may include a plurality of proximal ports at a first radial distance from the axis of rotation and a plurality of distal ports at a second, greater radial distance.

In some embodiments, the rotor valve face includes a fluidic selector 87, the fluidic selector 87 having an arcuate portion with a centerline that is arcuately equidistant from the axis of rotation and a radial portion that extends radially from the arcuate portion toward or away from the axis of rotation. In such embodiments, in the first rotor position, the first port 53a at a first radial distance from the rotational axis 16 may be fluidly connected to the second port 53b at a second radial distance from the rotational axis via the fluidic selector 87, and in the second rotor position, the first port is fluidly connected to the third port 53c at the second radial distance from the rotational axis via the fluidic selector, and wherein the first port remains fluidly connected with the fluidic selector as the rotor rotates between the first rotor position and the second rotor position.

In some embodiments, the rotor includes a plurality of flow channels 40, each flow channel including an inlet 41, an outlet 42, and a porous solid support 45. In certain embodiments, the rotor comprises a main body 11 and a cap (cap) 30 operatively connected to the main body, and wherein one wall of the flow path 40 is defined by the cap. The rotor includes an outer face 13 opposite the rotor valve face, where the outer face may include openings for engaging the splines.

In some embodiments, the rotary valve further comprises a seal 80 located between the stator face 52 and the rotor face 12, and wherein the stator comprises a displaceable spacer 60 for preventing the seal from sealing against at least one of the rotor 10 and the stator 50, and wherein the seal seals the rotor and the stator together in a fluid tight manner when the spacer is displaced. The retaining element 90 may include a retaining ring 91 and a biasing element 96. In a preferred embodiment, the retaining ring 91 is fixedly coupled to the stator 50 and the biasing element 96 is a spring that biases the rotor and stator together.

Another aspect of the invention provides a rotor comprising (a) a rotor valve face 12 perpendicular to a rotational axis 16 of the rotor, the rotor valve face configured to contact a flat stator face in a fluid-tight manner; and (b) a flow path 40, the flow path 40 configured to contain a porous solid support 45, wherein the flow path has an inlet 41 and an outlet 42 at the rotor valve face. The flow path 40 may include a porous solid support chamber 46 containing a solid support 45. In certain embodiments, the rotor valve face includes a fluidic connector 86. In some embodiments, the rotor valve face includes a fluidic selector 87, the fluidic selector 87 having an arcuate portion with a centerline that is arcuately equidistant from the axis of rotation and a radial portion that extends radially from the arcuate portion toward or away from the axis of rotation. The rotor may include a plurality of flow passages 40, each flow passage including a porous solid support 45. The rotor may also include a seal 80, the seal 80 being operatively connected to the rotor valve face 12.

Another aspect of the invention provides a rotary valve comprising: (a) A rotor 10, the rotor 10 comprising a rotor valve face 12, an outer face 13 opposite the rotor valve face, and an axis of rotation 16; (b) a stator 50; (c) a gasket 80 interposed between the stator and rotor valve faces; and (d) a displaceable spacer 60 for preventing the sealing gasket from sealing against at least one of the rotor and the stator, wherein the sealing gasket seals the rotor and the stator together in a fluid tight manner when the spacer is displaced. The rotary valve may further comprise a retaining element 90, the retaining element 90 biasing the rotor and the stator towards each other. In some embodiments, the retaining element 90 includes a retaining ring 91 and a biasing element 96. In some embodiments, the retaining ring 91 is fixedly coupled to the stator and the biasing element 96 is a spring. In certain embodiments, the rotor 10 includes at least one lip 21, and the displaceable spacer 60 includes a plurality of tabs (tabs) 61 displaceable from a storage configuration to an operating configuration, wherein each of the tabs 61 contacts the at least one lip 21, thereby preventing the sealing pad from sealing the rotor and stator in the storage configuration, and each of the tabs 61 disengages from the at least one lip when the tabs are displaced from the storage configuration to the operating configuration. At least one lip 21 may be an inner lip 23, and the rotor further comprises a displacer slot (28) adjacent the inner lip, wherein the displacer slot receives the inner tab 63 when the inner tab 63 is displaced to the active configuration. In some embodiments, the rotor 10 includes a curved outer wall 14, and the at least one lip 21 is a peripheral lip 22 located on the outer wall. In a preferred embodiment, the rotor comprises one or more cams 24, the cams 24 displacing the plurality of tabs 61 from the storage configuration to the active configuration when the rotor is rotated, thereby disengaging the plurality of tabs 61 from the at least one lip 21.

Another aspect of the invention provides a microfluidic network comprising (a) a valve as described herein; and (b) a plurality of microfluidic conduits 55, each being fluidly connected to one of the ports 53.

In yet another aspect of the invention, there is provided a method of purifying an analyte, the method comprising (a) providing a rotary valve as described herein; and (b) flowing a sample comprising the analyte through the flow path and retaining at least a portion of the analyte on the porous solid support to produce a bound analyte fraction (bound analyte fraction) and a depleted sample fraction (depleted sample fraction). In some embodiments, flowing the sample through the flow path comprises placing the rotor in a first rotational position, thereby fluidly connecting the first port, the flow path, and the second port. The sample may flow into the flow path via the first port and the depleted sample portion exits the flow path via the second port. A preferred embodiment of the method comprises rotating the rotor to a second rotational position to fluidly connect the third port, the flow path, and the further port, and then flowing an eluent into the flow path via the third port to release at least a portion of the analyte from the porous solid support to produce an analyte sample that exits the flow path via the fourth port.

Another aspect of the invention provides a method of producing a rotary valve, the method comprising: (a) Forming a stator comprising a stator face from a stator body material; (b) Forming a plurality of channels within the stator, each channel including a port at a face of the stator; (c) Forming a rotor comprising a rotor valve face from a rotor body material; (d) Forming a flow passage in the rotor, the flow passage including an inlet and an outlet at the rotor valve face; and (e) inserting a porous solid support into the flow path.

One aspect of the invention provides a method of storing a rotary valve, the method comprising: (ii) (a) placing a valve as described herein into a storage vessel; and (b) storing the valve for a period of time. In some embodiments, the storing of the valve includes holding the valve in a storage position with the gasket spaced apart from at least one of the rotor and the stator. Preferably, the period of time is 30 days or more, and more preferably, the period of time is 90 days or more.

Generally, in one embodiment, the rotary valve 00 includes a stator 50, a rotor 10, and a retaining element 90. The stator 50 includes a stator face 52 and a plurality of channels 54, each channel including a port 53 at the stator face. The rotor 10 is operatively connected to the stator and comprises an axis of rotation 16, a rotor valve face 12, and a flow path 40, the flow path 40 having an inlet 41 and an outlet 42 at the rotor valve face, wherein the flow path comprises a porous solid support 45. The retaining element 90 includes biasing the stator and rotor together at the rotor-stator interface 02 to form a fluid-tight seal.

This and other embodiments may include one or more of the following features. The cross-section of the flow passage 40 may not be concentric with the axis of rotation 16. The porous solid support may be a polymer. The porous solid support may be selected from the group consisting of: alumina, silica, diatomaceous earth, ceramics, metal oxides, porous glass, controlled pore glass, carbohydrate polymers, polysaccharides, agarose, sepharose ^TM 、Sephadex ^TM Dextran, cellulose, starch, chitin, zeolite, synthetic polymers, polyvinyl ethers, polyethylene, polypropylene, polystyrene, nylon, polyacrylates, polymethacrylates, polyacrylamides, polymaleic anhydride, membranes, hollow fibers and any combination thereof. The rotor valve face 12 may include a seal 80 interposed at the rotor-stator interface 02. The seal 80 may include a hole 83 therethrough, and wherein the stator may include an arcuate track 70 for laterally constraining the seal. The rotor valve face may include a fluidic connector 86, wherein in the first rotor position, the first port 53a of the stator may be fluidly connected to the second port 53b of the stator via the fluidic connector 86. The first port may be located at a first radial distance from the axis of rotation and the second port is located at a second, different radial distance. In the second rotor position, the third port 53c may be fluidly connected to the fourth port 53d via the fluidic connector 86. The rotor valve face may include a fluidic selector 87 having an arcuate portion with a centerline that is arcuately equidistant from the axis of rotation and a radial portion extending radially from the arcuate portion toward or away from the axis of rotation. In the first rotor position, the first port 53a at a first radial distance from the axis of rotation 16 may be fluidly connected to the second port 53b at a second radial distance from the axis of rotation via the fluidic selector 87, and in the second rotor position, the first port may be fluidly connected to the third port 53c at a second radial distance from the axis of rotation via the fluidic selector, and wherein the first port may remain fluidly connected to the fluidic selector when the rotor is rotated between the first and second rotor positionsAnd (4) connecting. The rotor may include a plurality of flow channels 40, each flow channel including an inlet 41, an outlet 42, and a porous solid support 45. The rotor may comprise a main body 11 and a cover 30 operatively connected to the main body, and wherein one wall of the flow path 40 may be defined by the cover. The rotary valve may further comprise a sealing gasket 80 located between the stator face 52 and the rotor face 12, and wherein the stator may comprise a displaceable spacer 60 for preventing the sealing gasket from sealing against at least one of the rotor 10 and the stator 50, and wherein the sealing gasket seals the rotor and the stator together in a fluid tight manner when the spacer is displaced. The retaining element 90 may include a retaining ring 91 and a biasing element 96. The retaining ring 91 may be fixedly coupled to the stator 50 and the biasing element 96 is a spring biasing the rotor and stator together.

Generally, in one embodiment, a rotary valve includes a rotor 10, a stator 50, a seal 80, and a displaceable spacer 60, the rotor 10 including a rotor valve face 12, an outer face 13 opposite the rotor valve face, and an axis of rotation 16, the seal 80 interposed between the stator and the rotor valve face, the displaceable spacer 60 for preventing the seal from sealing against at least one of the rotor and the stator, wherein the seal seals the rotor and the stator together in a fluid tight manner when the spacer is displaced.

This and other embodiments may include one or more of the following features. The valve may also include a retaining element 90, the retaining element 90 biasing the rotor and stator toward each other. The retaining element 90 may include a retaining ring 91 and a biasing element 96. The retaining ring 91 may be fixedly coupled to the stator and the biasing element 96 is a spring. The rotor 10 may comprise at least one lip 21 and a displaceable spacer 60, the displaceable spacer 60 comprising a plurality of fins 61 displaceable from a storage configuration to an operating configuration, wherein each of the fins 61 may contact the at least one lip 21, thereby preventing the sealing gasket from sealing the rotor and the stator in the storage configuration, and each of the fins 61 is disengaged from the at least one lip when the fins are displaced from the storage configuration to the operating configuration. At least one lip 21 may be an inner lip 23, and the rotor may further include a displacer slot 28 adjacent the inner lip, wherein the displacer slot receives the tab 63 when the tab 63 is displaced to the operational configuration. The rotor 10 may include a curved outer wall 14 and the at least one lip 21 is a peripheral lip 22 on the outer wall. The rotor may include one or more cams 24, the cams 24 displacing the plurality of tabs 61 from the storage configuration to the active configuration as the rotor rotates, thereby disengaging the plurality of tabs 61 from the at least one lip 21. The seal 80 may include a hole 83 therethrough, and wherein the stator may include an arcuate track 70 for laterally constraining the seal. The rotor may further comprise a flow path 40 having an inlet 41 and an outlet 42 at the rotor valve face, wherein the flow path may comprise a porous solid support 45. The outer face 13 may include openings for engaging splines.

In general, in one embodiment, a method of storing a rotary valve comprises: (1) placing the valve into a storage container; and (2) storing the valve for a period of time.

This and other embodiments may include one or more of the following features. Storing the valve may include maintaining the valve in a storage position, wherein the gasket may be spaced apart from at least one of the rotor and the stator.

Generally, in one embodiment, a rotary valve includes a rotor 10, a stator 50, a seal 80, and a retaining element 90. The rotor 10 has an axis of rotation 16, an outer face 13, and a rotor valve face 12 opposite the outer face 13, and a pair of

bores

41, 42 through the rotor valve face 12. The stator 50 has a stator face 52, the stator face 52 having a plurality of stator ports 53 therein, each of the plurality of stator ports 53 communicating with a fluid passage 54. A gasket 80 is interposed between the stator face 52 and the rotor valve face 12, the gasket 80 having an inner gasket sealing surface 81i and an outer gasket sealing surface 81o and a pair of gasket openings 83, the pair of gasket openings 83 being aligned with the pair of

holes

41, 42. The retaining element 90 biases the rotor and stator toward each other, placing the inner and outer gasket sealing surfaces 81i, 81o in fluid tight arrangement with the plurality of stator ports 53 in the stator face 52.

This and other embodiments may include one or more of the following features. The plurality of stator ports 53 may be arranged as a plurality of stator ports at a first radial spacing from the axis of rotation 16 and a plurality of stator ports at a second radial spacing from the axis of rotation 16, wherein fluid communication between one of the plurality of stator ports at the first radial spacing and one of the plurality of stator ports at the second radial spacing is provided by a fluid connector 86 extending between the inner gasket sealing surface 81i and the outer gasket sealing surface 81 o. The plurality of stator ports 53 may be arranged as a plurality of stator ports positioned circumferentially about the axis of rotation at a first radial spacing from the axis of rotation 16 and a plurality of stator ports positioned circumferentially about the axis of rotation 16 at a second radial spacing from the axis of rotation 16, wherein fluid communication between one of the plurality of stator ports at the first radial spacing and one or more of the plurality of stator ports at the second radial spacing is provided by a fluid selector 87 extending between the inner and outer gasket sealing surfaces 81i, 81o and along a portion of the outer gasket sealing surface 81 o. The plurality of stator ports 53 may be arranged as a plurality of stator ports positioned circumferentially about the axis of rotation at a first radial spacing from the axis of rotation 16, and the gasket 80 further comprises a fluid selector 87, the fluid selector 87 extending between the inner and outer gasket sealing faces 81i, 81o and along a portion of the outer gasket sealing face 81o, wherein fluid communication is provided by the fluid selector 87 between one of the plurality of stator ports at the first radial spacing and one or more of the plurality of stator ports at a second, different radial spacing from the axis of rotation and at a different circumferential position than the one of the plurality of stator ports at the first radial spacing. The gasket 80 may also include a fluid selector 87, the fluid selector 87 extending between the inner gasket sealing surface 81i and the outer gasket sealing surface 81o and along a portion of the outer gasket sealing surface 81 o. The gasket 80 may also include a fluid connector 86 extending between the inner gasket sealing surface 81i and the outer gasket sealing surface 81 o. The gasket 80 may further include a fluid selector 87 and a fluid connector 86, wherein in use, each stator port 53 is in communication with one of the fluid selector 87, the fluid connector 86, the inner gasket sealing surface 81i, the outer gasket sealing surface 81o, or the gasket opening 83. The gasket 80 may further include a fluid connector 86, wherein in use, each stator port 53 communicates with one of the fluid connector 86, the inner gasket sealing surface 81i, the outer gasket sealing surface 81o, or the gasket opening 83. A pair of

holes

41, 42 through the rotor valve face 12 may be an inlet and an outlet, respectively, of a fluid passageway 40, the fluid passageway 40 containing a porous solid support 45. The pair of

holes

41, 42 through the rotor valve face 12 may be a first pair of holes in communication with a first fluid passage 40 having a first solid support chamber 46, and the second set of

holes

41, 42 through the rotor valve face 12 in communication with a second fluid passage 40 having a second solid support chamber 46, wherein the first and second

solid support chambers

46, 46 contain a porous solid support 45. The porous solid support 45 may be a polymer. The porous solid support 45 may be selected from the group consisting of: alumina, silica, diatomaceous earth, ceramics, metal oxides, porous glass, controlled pore glass, carbohydrate polymers, polysaccharides, agarose, sepharose, sephadex, dextran, cellulose, starch, chitin, zeolite, synthetic polymers, polyvinyl ethers, polyethylene, polypropylene, polystyrene, nylon, polyacrylate, polymethacrylate, polyacrylamide, polymaleic anhydride, membranes, hollow fibers and any combination thereof.

Generally, the rotary valve includes a rotor 10, a stator 50, and a packing 80. The rotor 10 includes an outer face 13 and a rotor valve face 12 opposite the outer face 13, and a pair of

apertures

41, 42 through the rotor valve face 12. The stator 50 has a stator face 52, the stator face 52 having a plurality of stator ports 53 therein, each of the plurality of stator ports 53 communicating with a fluid passage 54. A seal 80 is interposed between the stator face 52 and the rotor valve face 12 with a pair of openings 83 in the seal aligned with the pair of

holes

41, 42, wherein the seal is spaced from the stator face 52 in the storage state and is held in fluid tight relationship with the stator face by a retaining element 90 when released from the storage state.

This and other embodiments may include one or more of the following features. The rotary valve may further include a retaining ring surrounding the rotor and coupled to the stator, the retaining ring may have a pair of arcuate shapes along a surface adjacent the rotor, and the rotor has a pair of complementary arcuate shapes corresponding to the pair of arcuate shapes in the retaining ring, wherein engagement of the pair of arcuate shapes with the pair of complementary arcuate shapes maintains the rotary valve in the storage state. The rotary valve may be released from the storage state by relative movement between the rotor and the retaining ring sufficient to disengage a pair of arcuate shapes along a surface adjacent the rotor from the pair of complementary arcuate shapes on the rotor. The rotary valve may also include a retaining ring surrounding the rotor and coupled to the stator. The retaining ring may have a plurality of grooves around a portion of the retaining ring adjacent the rotor, and the rotor has a plurality of complementary shapes that matingly correspond to the plurality of grooves in the retaining ring, wherein engagement of the plurality of grooves with the plurality of complementary shapes of the rotor maintains the rotary valve in the storage state. The rotary valve may be released from the storage state by relative movement between the rotor and the retaining ring sufficient to disengage a plurality of grooves around a portion of the retaining ring from a mating plurality of complementary shapes on the rotor. The rotary valve may further include a spacer disposed along the gasket sealing surface, wherein the spacer maintains a gap between the gasket sealing surface and the stator surface and maintains the rotary valve in a storage state. The rotary valve may be released from the storage state by relative movement between the rotor and the stator sufficient to displace the spacer to allow engagement between the gasket sealing surface and the stator surface. The rotary valve may further include a clip that engages the rotary valve to maintain a gap between the seal sealing surface and the stator surface and to maintain the rotary valve in a storage state. When the clip is removed, the rotary valve may be released from the storage state, allowing the retaining element to move the sealing gasket into fluid-tight relationship with the stator face.

Generally, in one embodiment, a rotary valve includes a rotor 10, a stator 50, and a retaining element 90, the rotor 10 having an axis of rotation 16, a rotor valve face 12, an outer face 13 opposite the rotor valve face, the stator 50 having a stator valve face positioned opposite the rotor valve face, the retaining element 90 biasing the rotor and stator toward each other, the retaining element 90 including a retaining ring 91 and a biasing element 96, wherein the rotary valve is maintained in a storage state when a threaded portion of the retaining ring engages a threaded portion of the rotor.

This and other embodiments may include one or more of the following features. Relative movement between the rotor and stator may create a fluid tight arrangement between the rotor valve surface and the stator valve surface. The relative movement between the rotor and the stator may be a rotation of the rotor to move the rotor along the threaded portion of the retaining ring. The rotation of the rotor to disengage the rotary valve from the storage state may be less than one revolution (revolution), half a revolution, quarter a revolution or eighth a revolution. The rotary valve may further comprise a sealing gasket disposed between the rotor valve face and the stator valve face, wherein the sealing gasket does not form a fluid tight seal with the stator valve face when the rotary valve is in the storage state. Relative movement between the rotor and the stator may create a fluid tight arrangement between the sealing gasket, the rotor valve face, and the stator valve face. The relative movement between the rotor and the stator may be a rotation of the rotor to move the rotor along the threaded portion of the retaining ring. The rotation of the rotor to switch the rotary valve from the storage state may be less than one revolution, half a revolution, quarter a revolution or eighth a revolution. When the rotor is out of storage and a sealing relationship is established between the rotor and the stator, the threaded portion of the rotor may be moved away (free of) from any other threaded portion of the rotary valve.

Generally, rotary valve 00 includes a stator 50, the stator 50 including a stator face 52 and a plurality of passages 54, each passage including a port 53 at the stator face; a rotor 10, the rotor 10 operably connected to the stator and comprising an axis of rotation 16, a rotor valve face 12, and a flow passage 40 having an inlet 41 and an outlet 42 at the rotor valve face, a solid support chamber in communication with the inlet 41 and the outlet 42, a porous solid support 45 located within the solid support chamber 46; and a retaining element 90, the retaining element 90 biasing the stator and rotor together at the rotor-stator interface 02 to form a fluid-tight seal.

This and other embodiments may include one or more of the following features. The solid support chamber may have a bottom and sidewalls and at least one flow path spacer along the bottom. The at least one flow path spacer may be elevated above the bottom of the chamber. The at least one flow path spacer may be recessed into the bottom of the chamber. The at least one flow passage spacer may be spaced from the outlet 42 and the sidewall of the chamber. The at least one flow passage spacer may be directly adjacent the outlet 42. The at least one flow passage spacer may have an arcuate shape corresponding to a curvature of a sidewall of the chamber. The at least one flow passage partition may extend from the outlet 42 towards the sidewall. The bottom of the chamber may be flat. The bottom of the chamber may be inclined from the side wall of the chamber towards the outlet 42. The porous solid support may be a polymer. The porous solid support may be selected from the group consisting of: alumina, silica, diatomaceous earth, ceramics, metal oxides, porous glass, controlled pore glass, carbohydrate polymers, polysaccharides, agarose, sepharose, sephadex, dextran, cellulose, starch, chitin, zeolite, synthetic polymers, polyvinyl ethers, polyethylene, polypropylene, polystyrene, nylon, polyacrylate, polymethacrylate, polyacrylamide, polymaleic anhydride, membranes, hollow fibers and any combination thereof. The rotary valve may be configured to remain in an initial stored condition (initial closed condition) without a fluid-tight seal between the rotor and the stator prior to the retaining element biasing the rotor and the stator into the fluid-tight seal arrangement. The rotary valve may have a rotor cover 30 covering each carrier chamber 46 in the rotor 10. The rotary valve may comprise a rotor cover 30 covering the entire rotor outer face 13, wherein the uncovered portions correspond to the one or more openings 17. The rotary valve may include a rotor cover 30, the rotor cover 30 having a bottom surface 34, the bottom surface 34 positioned to seal each solid support chamber 46 sufficient to complete a portion of the fluid pathway 40.

Generally, in one embodiment, a method of fluid treatment using a rotary valve includes rotating the rotary valve about the axis of rotation 16 to align a seal inlet 84 and a seal outlet 85 of a seal 80 with an inlet 41 and an outlet 42, respectively, of a fluid passageway 40 having a porous solid support 45 within a rotor 10 and to align the seal inlet 84 and the seal outlet 85 with a first pair of stator ports 53 in a stator valve face 52, and sealing a second pair of stator ports 53 in the stator valve face 52 with a portion of the seal 80.

This and other embodiments may include one or more of the following features. The method of fluid treatment may further include rotating the rotary valve about the axis of rotation 16 to align a first pair of stator ports 53 in the stator valve face 52 with the fluid passages 86 formed in the seal 80 or to align a second pair of stator ports 53 in the stator valve face 52 with the fluid passages 86 formed in the seal 80. The method of fluid treatment may further include rotating the rotary valve about the axis of rotation 16 to align at least one stator port of the first pair of stator ports 53 in the stator valve face 52 with at least one stator port 53 of the second pair of stator ports using the fluid passage 87 formed in the seal 80. The method of fluid treatment may further include rotating the rotary valve about the axis of rotation 16 to align at least one stator port of the first pair of stator ports 53 in the stator valve face 52 with at least one stator port 53 of the third pair of stator ports using the fluid passage 87 formed in the gasket 80. The method of fluid treatment may further include rotating the rotary valve about the axis of rotation 16 for flowing fluid through the first pair of stator ports 53 or the second pair of stator ports 53 before flowing fluid through the fluid passageway 40. The method of fluid treatment may further include rotating the rotary valve about the axis of rotation 16 for flowing the fluid through the fluid pathway 86 formed in the seal 80 or through the fluid pathway 87 formed in the seal 80 before flowing the fluid through the fluid pathway 40. The method of fluid treatment may further include rotating the rotary valve about the axis of rotation 16 to flow fluid through the first pair of stator ports 53 or the second pair of stator ports 53 after the fluid flows through the fluid passageway 40. The method of fluid treatment may further include rotating the rotary valve about the axis of rotation 16 for flowing the fluid through the fluid pathway 86 formed in the seal 80 or through the fluid pathway 87 formed in the seal 80 after flowing the fluid through the fluid pathway 40. The method of fluid treatment may further include flowing fluid through the first fluid channel 54 or the second fluid channel 54 after flowing fluid through the fluid pathway 40. The method of fluid treatment may further include flowing fluid through the first fluid channel 54 or the second fluid channel 54 before flowing fluid through the fluid pathway 40. The method of fluid treatment may further include positioning the rotary valve such that the fluid passes through the fluid passageway 86 formed in the seal 80 to the fluid channel 54 or through the fluid passageway 87 formed in the seal 80 to the fluid channel 54 after positioning the rotary valve such that the fluid passes through the fluid passageway 40. The method of fluid treatment may further include positioning the rotary valve to flow fluid through the fluid passageway 86 formed in the seal 80 or through the fluid passageway 87 formed in the seal 80 to the fluid channel 54 and storing a portion of the fluid in a storage chamber in communication with the fluid channel 54. The method of fluid treatment may further include positioning the rotary valve to flow fluid through the fluid pathway 86 formed in the seal 80 or through the fluid pathway 87 formed in the seal 80 to the fluid channel 54 and mixing a portion of the fluid with the lysis buffer. The method of fluid treatment may further include positioning the rotary valve such that the fluid from the mixing step flows through the fluid pathway 86 formed in the seal 80 or through the fluid pathway 87 formed in the seal 80 to the fluid pathway 40. The method of fluid treatment may further comprise positioning a rotary valve to flow the fluid from the mixing step through the porous solid support 45. The method of fluid treatment may further include positioning the rotary valve to flow fluid through the fluid passageway 86 formed in the seal 80 or through the fluid passageway 87 formed in the seal 80 to the waste chamber. The method of fluid treatment may further include positioning the rotary valve to align the pneumatic source with the fluid pathway 86 formed in the seal 80 or with the fluid pathway 87 formed in the seal 80. The method of fluid treatment may further include positioning the rotary valve to align the pneumatic source with the fluid pathway 40. The method of fluid treatment may further include positioning the rotary valve to flow water through the fluid pathway 40. The method of fluid treatment may further include positioning the rotary valve to flow water through the fluid pathway 86 formed in the seal 80 or through the fluid pathway 87 formed in the seal 80. The method of fluid processing may further comprise positioning the rotary valve to flow positive samples to the positive metering pathway and negative samples to the negative pooling pathway. The method of fluid treatment may further include entering the first fluid passage 54 via a first pair of stator ports 53 in the stator valve face 52, or entering the second fluid passage 54 via a second pair of stator ports 53. The method of fluid treatment may further include accessing a third fluid passage via a third pair of stator ports 53 in the stator valve face 52. The method of fluid treatment may further include positioning the gasket inlet 84 and the gasket outlet 85 against a portion of the stator valve face 52 without the stator ports 53. The method of fluid treatment may further comprise moving the rotary valve from the storage state to the ready to use state prior to the rotating step. The method of fluid treatment may further comprise the step of moving the rotary valve from the storage state to the ready to use state further comprising:

the seal 80 is moved into contact with the stator valve face 52. The method of fluid treatment may further include the step of moving the rotary valve from the storage state to the ready to use state, and may further include deflecting a displaceable spacer 60 that maintains a gap between the rotor and the stator, and moving a sealing gasket 80 into a fluid tight relationship with the stator valve face 52. The method of fluid treatment may further include the step of moving the rotary valve from the storage state to the ready to use state, and may further include rotating the rotor relative to the threaded retaining ring and moving the seal 80 into contact with the stator valve face 52. The method of fluid treatment may further include the step of moving the rotary valve from the storage state to the ready to use state, and may further include moving the rotor to displace the sacrificial edge 180 of the seal 80, and moving the seal 80 into contact with the stator valve face 52.

Drawings

The foregoing and other objects, features, and advantages will be apparent from the following description of particular embodiments of the invention, as illustrated in the accompanying drawings in which like reference characters refer to the same parts throughout the different views. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of various embodiments of the invention.

Fig. 1A, 1B1 and 1B2 provide several views of a rotary valve according to the invention as described herein. FIG. 1A provides a partial cross-sectional view of a rotary valve. Fig. 1B1 and 1B2 provide exploded perspective views of the same valve from a top perspective view (fig. 1B 1) and a bottom perspective view (fig. 1B 2).

Fig. 2A, 2B and 2C provide several perspective views of the rotor. Fig. 2A provides a perspective view of the main body of the rotor from the exterior face side. Fig. 2B provides a view of the same main body of the rotor from the valve face side. Fig. 2C provides a perspective view of the rotor main body with the seal gasket attached, from the valve face side.

FIG. 3A provides a perspective view of a rotor including a plurality of flow channels. Fig. 3B provides an enlarged view of a single solid support chamber within one of the flow paths.

FIG. 4 provides a cross-sectional perspective view of a valve illustrating an interface between a rotor and a stator according to an embodiment of the present invention.

FIG. 5A provides a bottom perspective view of an exploded illustration of an embodiment of a valve having a rotor with a center post. Fig. 5B is an enlarged view of a rotor cover for the rotor of fig. 5A.

Fig. 5C is a top perspective exploded view corresponding to the bottom perspective view of fig. 5A.

Fig. 5D is a partial cross-sectional view of the assembled valve of fig. 5A-5C.

FIG. 6 provides a perspective view of a stator of the rotary valve shown in FIG. 1B1 including an arcuate track and a number of ports.

Fig. 7A, 7B1 provide perspective views of embodiments of gaskets that slidably engage a stator.

Fig. 7B2 is a perspective view of the seal gasket of fig. 7B1 attached to a rotor.

Fig. 8A and 8B provide perspective and cross-sectional views, respectively, of the valve shown in fig. 5D in a storage position.

Fig. 9A and 9B provide perspective and cross-sectional views, respectively, of the valve of fig. 8A and 8B shifted to the operating position.

FIG. 10A is a perspective view of a threaded rotor for a rotary valve.

Fig. 10B is a side view of the threaded rotor of fig. 10A.

FIG. 10C is a cross-sectional view of the rotary valve with the threaded rotor of FIG. 10A positioned within the threaded retaining ring, the rotary valve in a storage state.

Fig. 11A and 11B are perspective cross-sectional and cross-sectional views of a rotary valve with a threaded rotor in a storage state.

Fig. 12A and 12B are perspective, cross-sectional and cross-sectional views of the rotary valve of fig. 11A and 11B, showing the threaded rotor out of storage and ready for use with a seal that forms a fluid-tight seal with the stator.

FIG. 13 is a partial cross-sectional view of a rotary valve in a storage state showing a spacer between the rotor and the stator.

Fig. 14A and 14B illustrate perspective views of a rotary valve with a slotted rotor in a storage state (fig. 14A) and a sealed/ready to use state (fig. 14B).

FIG. 15 is an exploded view of a rotary valve having a rotor spaced above and outside of the retaining ring.

FIG. 16 is a bottom cross-sectional view of a clamp for holding the rotary valve in a storage condition. The clamp includes a pair of prongs that are shown in position within the rotary valve to maintain a desired gap between the stator and rotor.

Fig. 17A and 17E provide top isometric views of alternative configurations of flow passage spacers within a solid support chamber.

Fig. 17B is a cross-sectional view of a solid support chamber with the flow passage spacer of fig. 17A.

Fig. 17C and 17D are cross-sectional views of a solid support chamber having a flat bottom (fig. 17C) or a sloped bottom (fig. 17D) with tapered or wedge-shaped flow path spacers thereon.

Fig. 18A-18C respectively show top cross-sectional views of a flow chamber having a plurality of flow passage spacers arrayed around the carrier chamber outlet, similar to those described above with respect to fig. 17A-17D, but recessed into the bottom of the carrier chamber.

FIG. 19 is a table depicting a series of sample processing steps that may be used to prepare a biological sample for bioassay analysis using the rotary valve described herein.

20A-30C depict rotary valve positions and operations of a rotary valve operated to perform exemplary steps as described in the table of FIG. 19.

Detailed Description

The details of various embodiments of the invention are set forth in the description below. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims.

Rotary valves and methods of using, manufacturing, and storing rotary valves are provided herein. The rotary valve includes a rotor and a stator that are biased toward each other to form a fluid-tight seal. In some embodiments, the rotor includes an integrated flow path that contains a porous solid support. Typically, the fluid-tight interface between the rotor and the stator is reinforced by a sealing gasket. Some embodiments of the rotary valve include a displaceable spacer to prevent a sealing gasket from sealing against at least one of the rotor and the stator prior to operation, wherein the sealing gasket seals the rotor and the stator together in a fluid tight manner when the spacer is displaced.

Before the present invention is described in greater detail, it is to be understood that this invention is not limited to particular embodiments described, and as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.

Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limit of that range and any other stated or intervening value in that stated range is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included in the smaller ranges, and are also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention.

In this document, some measurements or ranges may be indicated by a numerical value preceded by the term "about". The term "about" is used herein to provide literal support for the exact number following it, as well as numbers that are close or approximate to the number following the term. In determining whether a number is near or approximate to a specifically recited number, the near or approximate non-recited number may be a number that provides substantial equivalence of the specifically recited number in the context in which the number is given.

A flexible robust valve for microfluidic or mesofluidic applications is disclosed. The design of this valve allows its "flow control program" to be easily changed. The valve also includes the ability to filter with a solid phase extraction element built into the rotor of the valve; this simplifies the design and layout requirements associated with fluidic circuit design. Furthermore, the valve comprises an optional transport position, which avoids problems with compression set of the polymer in the valve surface.

Rotary valve

Rotary valves for moving, measuring, processing, concentrating, and/or mixing one or more fluids or components thereof are provided herein. The rotary valve comprises at least one rotatable valve member, i.e. a rotor, which is rotatable with respect to a stationary member (stator). The term stator denotes a frame of reference that evaluates the motion within the rotor system. When the stator remains stationary and the rotor moves in the reference frame of the valve, the stator may move relative to larger pieces of equipment or relative to the world.

In one aspect, the present invention provides a rotary valve comprising an integrated flow path that can hold a porous solid support for filtration, binding, and/or purification (purifying) of analytes in a fluid stream. In one embodiment, a rotary valve comprises: a stator 50, the stator 50 comprising a stator face 52 and a plurality of channels 54, each channel comprising a port 53 at the stator face; a rotor 10, the rotor 10 being operatively connected to the stator and comprising an axis of rotation 16, a rotor valve face 12, and a flow path 40 having an inlet 41 and an outlet 42 at the rotor valve face, wherein the flow path comprises a porous solid support 45; and a retaining element 90, the retaining element 90 biasing the stator and rotor together at the rotor-stator interface to form a fluid-tight seal.

In an active rotary valve, the rotor is operatively coupled to the stator by the action of a biasing element. As used herein, "operably connected" and "operably coupled" refer to being connected in a manner that allows the disclosed apparatus to operate and/or effectively perform a method in a manner described herein. For example, operably coupling may include removably coupling or fixedly coupling two or more aspects. As such, the operably connected aspects may be fixedly connected to each other and/or slidably connected to each other such that the operably connected aspects may slide along at least one surface of each other when the device is operated. The operably connected aspects may also be rotatably coupled such that one aspect (e.g., the rotor) rotates relative to the other aspect (e.g., the stator). Operably coupling may also include fluidly and/or electrically and/or matingly and/or adhesively coupling two or more components. Further, as used herein, "removably coupled" refers to being coupled in a manner, such as physically and/or fluidically and/or electrically, in which two or more coupled components may be separated and then repeatedly re-coupled.

The term "fluidic communication" as used herein refers to any conduit, passage, tube, pipe, or path through which a substance, such as a liquid, gas, or solid, may pass substantially unrestricted when the path is open. When the pathway is closed, the substance is substantially restricted from passing through.

Fig. 1A and 1B illustrate a rotary valve of the present invention comprising a rotor 10, a stator 50, and a biasing element 96 that maintains the rotor and stator in fluid-tight contact. The rotor and stator each include structure for handling and redirecting fluid flow. Fig. 1A provides a partial cross-sectional view with the flow path partially exposed, showing the solid support chamber 46 and the porous solid support 45 contained therein. Fig. 1B1 and 1B2 illustrate the rotary valve in exploded views, with the flow path 40 exposed on the exterior face (to be closed by the rotor cover 30) and the inlet 41 and outlet 42 visible at the valve face. The rotary valve of fig. 1B1 and 1B2 includes a seal 80 at the rotor valve face to enhance the seal between the rotor and the stator. Fig. 5A-5D provide additional details of another rotary valve embodiment having four flow paths. Additionally, the rotary valve embodiment illustrates the use of an inner biasing element 96a and an outer biasing element 96 b.

Rotor

In one aspect, a rotary valve includes a rotor having an integrated flow path that holds a solid support for purification, extraction, and/or concentration of an analyte. Fig. 2A, 2B, 2C, and 3A-3B illustrate typical rotors useful in the rotary valves described herein. Fig. 2A, 2B and 2C illustrate a rotor including a single flow passage. The solid support chamber 46 is most clearly visible in fig. 2A. Fig. 2B provides a view of the rotor from the rotor valve face 12, where the inlet 41 and outlet 42 of the flow path can be seen. Fig. 2C illustrates a rotor including a seal 80 at the valve face. Alternatively, as illustrated in fig. 3A, the rotor may include a plurality of flow passages. The rotor of fig. 3A includes four flow passages (46 a-46 d), which may be sized differently from one another.

The rotor is configured to rotate about an axis of rotation 16. For example, the rotor may rotate relative to the stator about an axis of rotation. Preferably, the rotor is symmetrical or substantially symmetrical about the axis of rotation. As used herein, "substantially" to a large or significant extent means, for example, almost entirely or almost entirely. In various aspects, the rotor is cylindrical or substantially cylindrical. While the main body of the rotor is preferably symmetrical about the axis of rotation, features such as the displaceable spacer interface, the advancement engagement opening and the fluid treatment element need not be symmetrically or substantially symmetrically placed with respect to the axis of rotation.

Rotors useful in the devices and methods described herein generally include a first face, such as valve face 12, and a second face opposite the first face, such as outer face 13. The valve face and/or the outer face may each be planar or have a planar portion. In this case, the axis of rotation of the rotor is perpendicular or substantially perpendicular to the valve face and/or the outer face. Furthermore, in a cylindrical rotor, the axis of rotation may be defined by and/or be part of the rotor that is equidistant or substantially equidistant from all points on the outermost radial edge of the rotor or on the outermost radial edge and/or the outer face of the rotor. The rotor valve face 12 optionally includes a gasket 80. The valve face will also typically include one or more fluid handling features, such as inlets and/or outlets of flow passages, fluidic connectors, or fluidic selectors. Where the rotor valve face includes a seal, fluid handling features are typically included in the seal.

In some embodiments, the rotor optionally includes a central opening 15 for receiving one or more portions of the stator (e.g., a central stator projection about which the rotor may rotate). The central opening of the rotor may also be configured to accommodate a biasing element and/or one or more displaceable spacers.

The rotor (e.g., a cylindrical rotor) has dimensions that include a diameter, such as a cross-sectional diameter, that may range from 3mm to 100mm, 5mm to 75mm, or 10mm to 50mm. Such diameters may also range from 3mm to 50mm, 5mm to 40mm, or 10mm to 30mm.

The rotor is configured to rotate with a rotating propulsion element (e.g., a spline operably coupled with the rotor). In some aspects, the exterior face of the rotor includes an opening defining an edge of the recess, a thrust engagement opening 17. Operably coupling the rotor and the spline includes engaging the opening with the spline. Such engagement includes inserting at least a portion of the spline (e.g., a protrusion) into the opening such that moving the protrusion in a rotational motion also exerts a force on the rotor such that the rotor rotates about the rotational axis. The portion of the spline may be inserted into the opening in a direction towards the stator and/or parallel to the rotational axis of the rotor. Further, in various embodiments, the rotor includes an advancement projection and the rotary advancement element includes an opening, such as an opening defining an edge of the recess, in which to receive the rotor projection to thereby engage the rotor with the advancement element.

In some embodiments (including the valves shown in fig. 2A and 3A), the rotor 10 includes a plurality (e.g., two, three, four, or more) of propulsion engagement openings 17 for engaging propulsion elements. Such an opening may be configured to receive a portion of a rotating propulsion element (e.g., a manual and/or automatic and/or electronic propulsion element, such as a spline) therein, such that the propulsion element may thereafter exert a force on the rotor to rotate the rotor. Typically, the advancement engagement openings are arranged concentrically about the rotational axis of the rotor. In other embodiments, the rotor includes a single advancement engagement opening that is generally, but not necessarily, coincident with the axis of rotation. Such a centrally located propulsion engagement opening is preferably non-circular to allow interaction with the propulsion element sufficient to generate the torque required to rotate the rotor relative to the stator.

In some versions, the valve of the present invention includes a plurality of pushing projections, such as projections forming a series of teeth projecting from the rotor (e.g., the outermost peripheral wall or rim of the rotor). Such a protrusion may be configured to operably engage with a series of receptacles for teeth on the rotary pusher member to rotate the rotor. In various embodiments, the configuration is reversed and the rotor includes a series of receptacles for the projections (e.g., teeth on the rotating pusher member). Thus, in some versions, the rotor portion forms a gear that interlocks with the propulsion element or a portion of the propulsion element, and the interaction of the gear drives rotation of the rotor.

In various embodiments, the rotor includes one or more flow paths configured for flowing one or more fluids (e.g., a sample or a fluid containing a sample) therethrough. As illustrated in fig. 4, each flow path 40 includes an inlet 41 at the rotor valve face 12, an outlet 42, and a solid support chamber 46. In many embodiments, the flow path 40 further includes a first conduit 43 that bridges from the inlet 41 to the solid support chamber 46. Such embodiments may also include a second conduit 44, the second conduit 44 bridging from the solid support chamber 46 to the outlet 42. The first conduit 43 and the second conduit 44 may have the same or different dimensions, such as length, volume or cross-sectional area. The cross-section of the first and second conduits may be uniform or may vary along the length of the conduits. In some embodiments, one conduit extends the entire thickness or almost the entire thickness of the rotor, i.e. from the valve face 12 to the outer face 13.

The cross-sectional view of fig. 4 illustrates the orientation of the rotor and stator, which establishes a fluid path between the stator fluid channel 54 (via stator ports 53a, 53 b) and the chamber 46 containing the porous solid support 45. The stator fluid passages 54 are not shown in this view, but are located within the stator body 51 (see fig. 1B 2). As a result, the flow passages 40 within the rotor body 11 provide fluid communication with the porous solid support 45 within the chamber 46. The flow path 40 can be accessed whenever the

gasket ports

84 and 85 are aligned with the two stator ports 53, which in this embodiment occurs when the

gasket ports

84, 85 are aligned with the stator ports 53a, 53b.

The fluid flow path through the solid support chamber 46 can also be seen in this view. The exemplary flow path begins at the stator 50 at the first port 53 a. Next is the path through the gasket 80 via the gasket inlet port 84. Next, the fluid enters the rotor body 11 via the inlet 41 and from there through the first fluid conduit 43. The outlet of the first conduit 43 opens into a fluid path defined by the spacing between the rotor upper surface 13 and the bottom surface 34 of the cover 30. The upper surface 13 in this region is shaped to provide a portion of the desired flow path between the first fluid conduit 43 and the chamber 46. This partial flow path is completed when the cover 30 is secured to the rotor top surface 13. Next, the fluid enters the chamber 46 containing the porous solid support 45. The fluid then flows to the bottom of the chamber 46, to the second conduit 44, and then to the rotor outlet 42. Fluid flows out of the rotor from the rotor outlet 42 and through the seal 80 via the outlet port 85 and to the stator opening 53b. Fluid continues to flow from the stator opening 53B via the stator fluid path 54 shown in fig. 1B 2.

As best seen in the view of fig. 4, an embodiment of the flow passage 40 may be present within the rotor main body 11. When provided, the flow passage 40 provides a fluid path between one or more ports in the rotor valve face 12 and the solid support chamber 46. With the rotor and stator aligned as shown in fig. 4, the fluid path 54 of the stator entering through the stator openings 53a, 53b communicates with the porous solid support 45 through the embodiment of fluid path 40 described above.

As an integral part of the rotor, the flow passage is configured for rotational movement, rotating with other parts of the rotor relative to other aspects of the valve (e.g. the stator). In a preferred embodiment, the flow passage is non-concentric with the axis of rotation of the rotor. As shown in fig. 4, the flow path may include one or more inlets 41 and one or more outlets 42 and provide flow control communication between the inlets and outlets. In a preferred embodiment, each flow path will include a single inlet and a single outlet. The inlet and outlet will typically, but not necessarily, take the same form as the cross-section of the flow path immediately adjacent the inlet or outlet. The inlet and/or outlet may be circular, rectangular, or any other suitable shape consistent with forming a fluid-tight, fluidic connection within the valve interface.

In many embodiments, the devices of the present invention are disposable and/or intended to be single use, while other valves are not disposable and are intended to be used multiple times. In addition, the device of the present invention can support more complex circuits in less space than existing valve designs. Furthermore, the integration of the porous solid support into the rotor of the valve improves the fluidic layout associated with the use of the valve.

In various embodiments, flow path 40 includes a porous solid support chamber 46 in which a porous solid support 45 is retained. The porous solid support chamber 46 may be cylindrical, or may take any other shape to accommodate any configuration of the porous solid support 45 provided herein. Other shapes for the carrier chamber 46 include polygonal or other multi-faceted shapes, including shapes having multiple curved faces or a combination of curved and straight faces. Additionally or alternatively, the side walls of the carrier chamber may be straight or angled. In the angled arrangement, the chamber 46 is wider nearer the first conduit 43 and narrower nearer the second conduit 44. In addition to the porous solid support, the porous solid support chamber may also include a supplemental volume for containing fluid flowing through the chamber prior to the fluid flowing through the porous solid support. See, for example, the headspace above the porous solid support 45 in the chamber 46 in fig. 4, which is located between the upper surface of the porous solid support 45 and the bottom surface 34 of the lid. The supplemental volume can have a volume equal to, less than, or greater than the volume of the porous solid support 45. The flow path 40 and the solid support chamber 46 may be configured to flow fluid through the chamber substantially parallel to the axis of rotation, for example as shown in fig. 4. In some configurations, the first and

second conduits

43, 44 are arranged within the rotor so as to provide a flow path parallel to the rotational axis 16 of the rotor. Alternatively, the flow path and solid support chamber may be configured such that the flow of fluid through the chamber is parallel to the rotor valve face. Although the volume of the solid support chamber is contained primarily within the main body of the rotor, one or more walls of the solid support chamber may be formed by a separate element (e.g., rotor cover 30).

In various embodiments, including the embodiment shown in fig. 3A, two or more (e.g., all) of the flow paths, or portions thereof (e.g., the porous solid support chambers), have different cross-sectional diameters. For example, the diameter of the solid support chamber 46a is narrower than the diameter of the solid support chamber 46 c. In some versions, none of the flow passages or portions thereof (e.g., the porous solid support chambers) have the same cross-sectional diameter. In other embodiments, two or more of the plurality of flow passages, or portions thereof (e.g., the porous solid support chambers), have the same cross-sectional diameter. As with the flow passages, the solid support chamber is preferably not concentric with the axis of rotation of the rotor. It should be appreciated that the flow path spacers 49 within the flow paths may vary between flow paths on the rotary valve as further described with reference to fig. 17A-18C. Fig. 18A shows one specific example of different fluid spacers on a single rotor.

Fig. 3B provides an enlarged view of a portion of the rotor. The rotor includes a flow passage 46b. Optionally, the flow path further comprises flow path spacers 49 for spacing the porous solid support from a surface (e.g., bottom surface) of the porous solid support chamber. In various embodiments, the flow passage spacer may be crescent-shaped and extend in an arcuate manner along its length. The flow passage spacer may facilitate fluid flow through the outlet by preventing the porous solid support (e.g., beads or fibers) from physically blocking the outlet of the solid support chamber.

The solid support chamber 46 is configured to hold one or more porous solid supports 45. The porous solid support can be configured to capture an analyte from a sample flowing therethrough and thereby concentrate the analyte (e.g., concentrate the analyte from a first concentration to a second concentration) by an amount of analyte concentration, e.g., 1000-fold or more, in any amount of time described herein (e.g., within 30 minutes or less, e.g., within 1 hour or less). In various embodiments, the porous solid support is defined, for example, by a frit (frit) on the upstream face and/or the downstream face.

In some aspects, the porous solid support may be a selective membrane or a selective matrix. As used herein, the term "selective membrane" or "selective matrix" refers herein to a membrane or matrix that retains one substance (e.g., an analyte) more effectively (e.g., substantially more effectively) than another substance (e.g., a liquid, e.g., a portion of a sample other than the analyte and/or water and/or a buffer) when the substance is exposed to a porous solid support and at least one of the substances moves at least partially therethrough. For example, a porous solid support (e.g., selective matrix) through which a biological sample flows may retain an analyte (e.g., nucleic acid) while the remainder of the sample passes through the porous solid support.

Examples of porous solid supports include, but are not limited to: alumina, silica, diatomaceous earth, ceramics, metal oxides, porous glass, controlled pore glass, carbohydrate polymers, polysaccharides, agarose, sepharose ^TM 、Sephadex ^TM Dextran, cellulose, starch, chitin, zeolite, synthetic polymer, polyvinyl ether, polyethylene, polypropylene, polyphenylEthylene, nylon, polyacrylate, polymethacrylate, polyacrylamide, polymaleic anhydride, films, hollow fibers and fibers, or any combination thereof. The choice of matrix material is based on considerations such as the chemistry of the affinity ligand pair (affinity ligand pair), the ease with which the matrix can be adapted to the particular binding desired.

In some embodiments, the porous solid support is a polymeric solid support and comprises a polymer selected from polyvinyl ether, polyvinyl alcohol, polymethacrylate, polyacrylate, polystyrene, polyacrylamide, polymethacrylamide, polycarbonate, or any combination thereof. In one embodiment, the solid support is a glass fiber based solid support and comprises glass fibers that may optionally be functionalized. In some embodiments, the solid support is a gel and/or a matrix. In some embodiments, the solid support is in the form of beads, particles, or nanoparticles.

In various aspects, the porous solid support comprises a plurality of magnetic beads. Such beads may be sized such that the beads remain in the flow path during a loading step in which the sample flows into the flow path and/or the porous solid support. Beads may also be retained in the flow path during the washing step as buffer flows through the path and/or the porous solid support. The beads may also have a size and/or magnetic content such that they may be released from the flow path during the elution step. This release may be achieved by changing or removing the magnetic field, wherein the beads are held in the passage. In the elution step, the beads can flow out of the rotor and/or into the stator for subsequent elution.

A myriad of functional groups (functional groups) can be employed in embodiments of the present invention to facilitate attachment of sample analytes or ligands to the porous solid support. Non-limiting examples of such functional groups that may be located on the porous solid support include: amines, thiols, furans, maleimides, epoxies, aldehydes, alkenes, alkynes, azides, azlactones, carboxyls, active esters, triazines, and sulfonyl chlorides. In one embodiment, amine groups are used as functional groups. The porous solid support may also be modified and/or activated to include one or more functional groups, so long as the functional groups facilitate immobilization of the appropriate ligand or ligands to the support.

In some embodiments, the porous solid support has a surface comprising reactive chemical groups capable of reacting with a surface modifier that attaches a surface moiety (e.g., a surface moiety of an analyte or ligand of a sample) to the solid support. Surface modifiers may be used to attach the surface moieties to the solid support. Any surface modifying agent capable of attaching the desired surface moiety to a solid support may be used in the practice of the present invention. A discussion of the reaction of surface modifying agents with solid supports is provided in the following references: the reaction of surface modifiers with Porous solid supports is described in "Porous Silica (pores Silica)", k.k.unger, p.108, eisenvirgins scientific press, new york, n.y. (1979), the entire disclosure of which is incorporated herein by reference, for all purposes, the description of the reaction of surface modifiers with various solid support materials is provided in "Chemistry and Technology of silicone resins" (Chemistry and Technology of Silicones) ", w.nonocho, new york, n.y. (1968), the disclosure of which is incorporated herein by reference for all purposes.

In some embodiments, the rotor includes a cover at an exterior face of the rotor. In some aspects, the cover is integral with the rotor main body and, as such, is constructed from the same single sheet of integrated material (comprising one material or multiple materials) as the main body. In other versions, the lid itself is an integral plastic body that is operably coupled to the main body. In some embodiments, the cap 30 is operatively connected to the main body of the rotor, and one wall of the flow path is defined by the cap. A rotor cover 30 may cover each of the solid support chambers as part of the fluid passageway 40. As shown in FIG. 3B, the shape, size, dimension, volume of each support chamber 46a-46d or the content of solid support contained in a particular support chamber 46 may vary. The rotor cover 30 may accordingly be configured to cover the entire upper surface of the rotor or only the solid support chamber.

In some versions, such as illustrated in fig. 4, the lid 30 includes a film, such as a polymer, e.g., plastic, and/or a metal film, e.g., foil. The membrane may optionally include an opening 38 to allow the splines to enter the advancing engagement opening in the rotor. Alternatively, the membrane may be pierced by splines of other tools.

In other versions, such as illustrated in the inset of fig. 5B, the cover 30 includes an integral plastic body. The cover of fig. 5B includes a plurality of openings (i.e., cutouts) 38 to allow the pusher elements to enter the pusher engagement openings of the rotor. In some embodiments, the cover 30 further includes a central opening 36 for receiving one or more portions of a stator therein, such as a central stator projection about which the rotor may rotate. In a preferred embodiment, a portion of the lid (flow path surface 34) forms a wall of the flow path or a portion thereof (e.g., a solid support chamber). The cover may be made of an opaque material. In this version, the cap 30 may also include a plurality of flow path mating elements 32 for operatively connecting the cap with the flow path. The flow path mating element may be a structure that engages the flow path and frictionally holds the cap in place. In another preferred embodiment, the flow path mating element may be welded to the main rotor body, or bonded with an adhesive element, to provide a secure bond between the main rotor body and the cover structure and prevent leakage of the flow path during valve operation. In some versions, the cover may be removably coupled and/or adhesively attached to the main body such that it may be removed and/or replaced by another cover.

Stator

The stator is an integral part of each rotary valve described herein. Stators that can be used in the devices and methods described herein include a first face, e.g., a stator face. The stator face is planar or has a planar portion. In the assembled valve, the stator face is perpendicular or substantially perpendicular to the axis of rotation of the rotor and is substantially complementary to the valve face of the rotor. The stator face optionally includes a gasket 80 to facilitate a fluid-tight seal at the rotor-stator interface. The stator may have additional faces, such as an anchoring face defining a second surface of the stator.

FIG. 6 provides one embodiment of a stator of a rotary valve for use in practicing the method of the present invention. In various embodiments, the stator includes a stator face 52 and a plurality of channels, each channel including a port 53 at the stator face 52, e.g., an opening configured for passage of a fluid therethrough. The plurality of channels may range from 2 to 80, such as 2 to 36, such as 4 to 18. The ports may be defined by the edges of an opening (e.g., a circular or rectangular opening) in the stator face. The ports can be of any size, such as the cross-sectional diameter of any channel (e.g., microfluidic channels provided herein).

In one embodiment, the stator ports are radially distributed around the center of the stator face. In a preferred embodiment, when assembled into a rotary valve, two or more stator ports are located at a first distance from the rotational axis of the rotor and the other two or more stator ports are located at a second, different distance from the rotational axis. In some embodiments, there are an equal number of stator ports at the first distance and at the second distance. Optionally, there may be more or fewer stator ports at the first and second distances from the axis of rotation. Fig. 4 illustrates certain features of the stator in the case of an assembled rotary valve. In particular, the cross-sectional view shows two stator ports at different distances from the axis of rotation. The first port 53a is remote from the axis and is aligned with the inlet 41 of the flow passage in the rotor. The second port 53b is closer to the axis and is aligned with the outlet 42 of the flow path. In other configurations, stator ports at different distances from the axis of rotation may interact with fluid handling features (e.g., connectors or fluidic selectors). Those skilled in the art will appreciate that additional stator ports may be positioned equidistant from the third distance, the fourth distance, and the axis of rotation.

Each channel 54 in the stator includes at least two ends, one end at the stator valve face and a second end terminating at an orifice leading to another structure (e.g., a sample holding chamber, a lysis chamber, or an outlet to the environment), or also present at the stator valve face. In certain embodiments, the second end may include a frangible seal that initially prevents flow through the passage, but may be broken during operation of the device to allow flow through the passage. In a preferred embodiment, the channel is a microfluidic feature having a minimum dimension of 750 μm or less. In other embodiments, the minimum dimension may be 600 μm or less, 500 μm or less, 400 μm or less, 200 μm or less, or 100 μm or less. The channel may comprise any cross-sectional shape, preferably rectangular. In some embodiments, each channel is completely embedded within the stator main body except for the ends. In other embodiments, the at least one channel extends through the stator main body to the anchoring face and then as an exposed conduit along the anchoring face of the stator. Such exposed channels may terminate on the anchoring face or, alternatively, may pass through the stator to an aperture at a structural feature (e.g., a chamber, well or tube connector).

Rotor-stator interface

In an embodiment of the invention, the rotor contacts the stator at an interface to form a fluid tight seal. In such embodiments, the fluid-tight seal completely or substantially prevents fluid from leaking out via the interface during operation of the device. Such fluid may be a sample, buffer, or other fluid flowing through the components of the apparatus including the rotor and stator according to embodiments of the present invention. The fluid-tight seal is maintained as the rotor rotates relative to and slides along the stator.

According to various embodiments, the valve includes a retaining element biasing the stator and the rotor together. The retaining element may comprise a retaining ring and/or a biasing element. The holding element (1) holds the rotor and stator in proximity to each other, and (2) biases the two elements together to form a leak-proof interface. In some embodiments, a single structure both maintains proximity and provides a biasing force. In other embodiments, a first structure (e.g., a retaining ring) aligns the rotor and the stator, and a second structure (e.g., a biasing element) presses the rotor and the stator together.

The holding element may be movable or stationary relative to the stator. For example, the propulsion element, in addition to rotating the rotor, may also propel the rotor into the stator to form a leak-proof interface. In a preferred embodiment, at least a portion of the holding element is stationary relative to the stator. In one embodiment, the retaining element includes a retaining ring and a biasing element, wherein the retaining ring is fixedly coupled to the stator such that the rotor is retained between the retaining ring and the stator. In some embodiments, the retaining ring provides sufficient force to form a leak-proof seal between the rotor and the stator.

In other embodiments, the retaining element comprises a retaining ring 91 and a separate biasing element 96. The retaining ring is coupled to the stator, for example, by one or more coupling protrusions 57 on the stator and corresponding retaining ring attachment elements 94 (see, e.g., fig. 1A). By this coupling, the retaining ring may be configured to be fixed in a position as the rotor rotates relative to the retaining ring and the stator. The retaining ring may be coupled to the stator by any method known in the art, such as by heat staking or ultrasonic welding the coupling protrusions or using a standard retainer, such as a push nut 98 (see, e.g., fig. 8A).

The retaining ring is configured to provide a stationary base for the biasing element such that the biasing force can be used to hold the rotor in contact with the stator. In one embodiment, the retaining ring includes a face, such as a flat and/or annular lip 93, for contacting a biasing element 96, such as a spring. Such faces may lie in planes parallel to the outer face and/or the valve face and/or the stator face. Similarly, the biasing element will typically engage the rotor along a face on the rotor (e.g., a flat and/or annular lip 21). The flat lip may be a peripheral protrusion on the rotor, i.e. a peripheral lip 22 (see e.g. fig. 3A and 8B). In some embodiments, the flat face may be formed more centrally, such as the inner lip 23 shown in fig. 8A and 8B.

The retaining ring may also include a splined access opening, which may be a circular opening opposite the stator. The spline access opening may be configured to receive a portion of a rotary pusher member (e.g., a spline) therethrough while the spline engages the rotor to rotate the rotor.

The biasing element is shaped as a ring positioned around at least a portion of the rotor. The biasing element may also be substantially circular, e.g. annular, and/or cylindrical, and/or may have a central axis that is concentric or non-concentric with the rotational axis of the rotor. Preferably, the biasing element provides a substantially symmetrical force relative to the axis of rotation so as to bias the rotor evenly against the stator without tilting.

The biasing element may be one or more springs. In embodiments where the biasing element is a spring, the spring may be a compression spring or an extension spring made of metal, plastic, or other polymer. In various embodiments, the biasing element is a band spring, such as an annular band spring. In various embodiments, the biasing element is a wave spring, such as an annular wave spring. The biasing element may also be shaped as a cylindrical post and may be comprised between two parts, e.g. a rotor and/or a stator and/or a holding element.

The biasing element may be a block of resilient material (e.g., rubber or foam) in the shape of a block, cylinder, ring, ball, or other shape. The biasing element may be in the form of one or more rubber bands. The biasing element may be in the form of one or more pieces of metal, plastic, or other polymer that are shaped to apply sufficient force to the other device components. Such a shaped metal piece may comprise a metal strip that is curved, for example, within a rotating ring. The biasing element may be in the form of a magnet or a series of magnets configured to repel or attract each other, thereby applying sufficient force to the device components. The biasing element may be made of the same material as any other valve component (e.g., a gasket). In some embodiments, the biasing mechanism may be part of, e.g., integral with, another component (e.g., the rotor and/or the retaining ring and/or the stator). As used herein, "integral" and "integrated with" refer to being constructed from a single piece of integrated material (material or materials).

Sealing gasket

In some aspects, the rotary valve includes a seal between the stator face and the rotor face. Gaskets are mechanical seals that fill the space between two or more mating surfaces of objects, typically to prevent leakage from or into the engaged objects when the gasket is compressed. In various aspects, the gasket is constructed of a resilient and/or compressible material, such as entirely constructed of a resilient and/or compressible material. In some versions, the rotor includes a seal, while in other versions, the stator includes a seal. In embodiments where the rotor includes a gasket, the gasket is fixedly (e.g., adhesively) attached to the rotor and forms a sliding interface along the stator. Further, in those embodiments in which the stator includes a gasket, the gasket is fixedly (e.g., adhesively) attached to the stator and forms a sliding interface along the rotor.

Fig. 7A and 7B 1-7B 2 illustrate one embodiment of a valve device component. Specifically, fig. 7A and 7B 1-7B 2 illustrate a gasket 80 that slidably engages the stator. The seal 80 also includes a first aperture 84 aligned with the inlet 41 of the rotor flow path and a second aperture 85 aligned with the outlet 42.

In various aspects, the seal is substantially cylindrical and/or disc-shaped, wherein a distance between the axis of rotation and an outer circumference of the seal is greater than a distance between the axis of rotation and a furthest port on the stator. In some embodiments, as illustrated in fig. 7A and 7B 1-7B 2, the gasket is annular with an outer circumference beyond the farthest stator port as described above, and wherein the distance between the axis of rotation and the inner circumference of the ring is less than the distance between the axis and the nearest stator port. The seal may have an outer cross-sectional diameter, such as any of the rotor diameters provided herein. The gasket may have an outer cross-sectional diameter of, for example, 100mm or less, for example 45mm or less, for example 50mm or less, for example 40mm or less, for example 20mm or less, for example 10mm or less. The inner and outer diameters of the gasket may range, for example, from 1 to 100mm, 3mm to 50mm, 3mm to 25mm, or 5mm to 35 mm. The gasket may also have a thickness of any thickness, such as the device components provided herein, such as 10mm or less, such as 5mm or less, such as 1mm or less or 1mm or more, 5mm or more, or 10mm or more.

In various aspects, the gasket is constructed of, such as entirely constructed of, one or more polymeric materials (e.g., materials having one or more polymers, including, for example, plastics and/or rubbers and/or foams). The gasket may also be constructed of a silicone material. The gasket may be constructed of any of the elastomeric materials provided herein. Gasket materials of interest include, but are not limited to: polymeric materials, e.g. plastics and/or rubbers, e.g. polytetrafluoroethylene (polytetrafluoroethene) or Polytetrafluoroethylene (PTFE), including expanded polytetrafluoroethylene (e-PTFE), polyesters (Dacron @) ^TM ) Nylon, polypropylene, polyethylene, polyurethane, and the like, or any combination thereof. In some embodiments, the gasket comprises neoprene (polychloroprene), silicone, polydimethylsiloxane, fluoropolymer elastomer (e.g., VITON) ^TM ) Polyurethanes, thermoplastic vulcanizates (TPVs, e.g. Santoprene) ^TM ) Butyl rubber or styrene block copolymer (TES/SEBS).

According to some embodiments, the gasket comprises one or more holes that penetrate completely through the thickness of the gasket. In these embodiments, where the gasket is secured to the stator, the gasket includes an aperture corresponding to and aligned with each stator port to allow fluid to flow through the aperture. In embodiments in which the seal is secured to the rotor, the seal includes holes corresponding to and aligned with each of the flow passage inlet and outlet (if present) to allow flow through the rotor-stator interface.

When fluid is forced through the openings of the gasket, the pressure of the pushing fluid deforms the inherently resilient material of the gasket. To minimize such distortion that may lead to leakage at the rotor-stator interface, some versions of the stator include one or more arcuate tracks, such as first and second arcuate tracks, for laterally engaging the seal to inhibit deformation of the seal when one or more fluid-handling elements (e.g., grooves or holes) of the seal are pressurized. Lateral engagement means contacting and exerting a force on another element in a substantially radially outward and/or inward direction with respect to the axis of rotation of the rotor and/or in a plane concentric with the axis of rotation of the rotor and having the same thickness as the axis. Lateral engagement may also refer to contacting another element and applying a force to the other element in a direction substantially perpendicular to the axis of rotation of the rotor.

In various embodiments, one or both of the arcuate tracks are annular and may be concentric with the axis of rotation. In various embodiments, the arcuate tracks are circular and the diameter of the first arcuate track is less than the diameter of the second arcuate track. In one embodiment, the stator 50 includes two arcuate rails, wherein the proximal rail 71 is located proximal to the channel and limits the gasket from deforming toward the axis of rotation, and wherein the distal rail 72 is located distal to the channel and limits the gasket from deforming away from the axis of rotation. In embodiments having two arcuate rails, the rails are preferably positioned to support the fluidic features of the gasket. For example, fig. 6 illustrates a stator having two arcuate tracks. On rails, the proximal rail 71 is positioned closer to the axis of rotation than the gasket hole that engages the stator port. The second, distal rail 72 is positioned further from the axis of rotation so that the further gasket holes engage the stator ports. In another embodiment, the gasket is fixed to the stator and the arcuate track is integrated in the rotor.

Pressurizing may include increasing the pressure in the one or more ports from a first pressure (e.g., one atmosphere or substantially one atmosphere) to a second pressure greater than the first pressure. The second pressure may exceed one atmosphere, such as 1.2 atmospheres or more, 1.5 atmospheres or more, 2 atmospheres or more, or 5 atmospheres or more. Pressurizing may include laterally engaging (e.g., by contacting) at least one of the arcuate rails and at least one of the gaskets to form a fluid-tight seal between the arcuate rails and the gaskets. The lateral engagement may include moving at least a portion of the seal (e.g., the projecting ring) toward the arcuate track of lateral engagement thereof. When a fluid tight seal is formed, no or substantially no liquid leaks through the seal during operation of the device as a whole. Further, in some versions, the stator further includes a second arcuate track concentric with the first arcuate track. In such embodiments, pressurizing the port includes transversely engaging the second arcuate rail and the gasket to form a fluid-tight seal therebetween.

Fluid treatment

The rotary valves described herein may be used to direct fluid flow within a device, particularly a microfluidic device. As such, the rotary valve includes at least one fluid handling feature. In some embodiments, the fluid handling features are contained within the rotor valve face. In embodiments where the rotor includes a seal, the seal may include one or more fluid handling features.

As used herein, a fluid handling feature is a physical structure in the rotor or seal that, when aligned with two stator ports, fluidly connects the two ports and associated channels to form a continuous fluidic path. In some embodiments, the fluid handling feature is fluidic connector 86. The fluidic connector is configured to fluidly connect the first stator port to the second stator port. In an embodiment, as shown in fig. 7A-7B 2, the fluidic connector is an elongated groove in the rotor or gasket having a longest dimension along a line radiating from the center of the rotor. Such radially aligned fluidic connectors can sequentially connect pairs of stator ports, as shown in fig. 6, where each pair of stator ports of the plurality has one proximal port and one distal port, where all proximal ports are located at one distance from the axis of rotation and all distal ports are located at a second, greater distance from the axis. In some embodiments, the fluid handling feature is a flow passage, wherein when the flow passage inlet is aligned with one stator port and the flow passage outlet is aligned with a second stator port, the entire volume of the flow passage fluidly connects the two stator ports. Thus, the flow passage may act as a fluidic connector. In some embodiments, the fluid handling feature is a fluidic selector 77 having a first portion that is arcuate with all points along the first portion equidistant from the axis of rotation and a second portion that extends radially toward or away from the center of the rotor.

One aspect of the invention provides a rotary valve having a rotor, wherein a rotor valve face comprises a first flow control connector, wherein in a first rotor position, a first port of a stator is fluidly connected to a second port of the stator via the first connector. In the second rotor position, the third port is fluidly connected to the fourth port via the first flow control connector. Optionally, in the third rotor position, the fifth port is fluidly connected to the sixth port via the first flow control connector. In one embodiment, the fluidic connector is an elongated groove. In another embodiment, the fluidic connector is a flow passage in the rotor.

One aspect of the present invention provides a method of purifying an analyte, the method comprising (1) providing a rotary valve comprising (a) a stator 50, the stator 50 comprising a stator face 52 and a plurality of channels 54, each channel comprising a port 53 at the stator face; (b) A rotor 10, the rotor 10 being operatively connected to the stator and comprising an axis of rotation 16, a rotor valve face 12 and a flow path 40 having an inlet 41 and an outlet 42 at the rotor valve face, wherein the flow path comprises a porous solid support 45; and (c) a retaining element 90, the retaining element 90 biasing the stator and rotor together at the rotor-stator interface to form a fluid-tight seal; and (2) flowing a sample comprising the analyte through the flow path and retaining at least a portion of the analyte on the porous solid support to produce a bound analyte fraction and a depleted sample fraction. In some embodiments, the method further includes rotating the rotor about the axis of rotation to a first position, thereby fluidly connecting the first port, the flow passage, and the second port. In the first position, the sample flows into the flow path via the first port and the depleted sample portion exits the flow path via the second port. In another embodiment, the stator includes four ports and the method further includes rotating the rotor to the second position, thereby fluidly connecting the third port, the flow passage, and the another port. In the second position, the elution fluid flows into the flow path via the third port, thereby removing at least a portion of the analyte from the porous solid support to produce an analyte sample that exits the flow path via the fourth port. As used herein, the term "eluent" refers to a solvent used to achieve effective separation of an analyte from a solid support by elution.

In some versions, the disclosed valve devices are fluidic sample processing devices and/or sample processing devices, which may be biological assay devices, such as biological assay sample preparation or processing devices. As used herein, a "bioassay" is a test on a biological sample that is performed to evaluate one or more characteristics of the sample. A biological sample is a sample containing an amount of organic matter (e.g., one or more organic molecules, e.g., one or more nucleic acids, e.g., DNA and/or RNA, or portions thereof), which can be taken from a subject. The biological sample may include one or more of blood, urine, mucus, or other bodily fluids. Thus, according to some embodiments, a biological assay sample preparation device is a device that prepares a biological sample for biological assay analysis. Also in some aspects, the biological sample is a nucleic acid amplification sample, which is a sample that includes one or more nucleic acids, or portions thereof, that can be amplified according to embodiments of the invention.

Manufacturing method

One aspect provides a method of producing a rotary valve, the method comprising: (a) Forming a stator 50 comprising a stator face 52 from a stator body material; (b) Forming a plurality of channels 54 within the stator, each channel comprising a port 53 at the face of the stator; (c) Forming a rotor 10 comprising a rotor valve face 12 from a rotor body material; (d) Forming a flow passage 40 in the rotor, the flow passage 40 comprising an inlet 41 and an outlet 42 at the rotor valve face; and (e) inserting a porous solid support 45 into the flow path. In some embodiments, the method further comprises operably connecting the stator and the rotor such that the rotor is configured to rotate about an axis of rotation.

Each of the components of the inventive device or aspects thereof, such as the stator, rotor, seal, displaceable spacer, biasing element, retaining ring, cover and/or cam, may be constructed of various materials (e.g., a single material) or more materials (e.g., two, three, four, five or ten or more materials). In various aspects, the components may also include one or more rigid materials, such as polymeric materials, e.g., plastics. In some aspects, such components may include one or more flexible materials, such as a layer of flexible material coated with a core (core) composed of one or more rigid materials. In various aspects, the components can include one or more elastomeric materials. The resilient material is a material that is flexible and also retains its original shape when a force is applied thereto. For example, the sealing gasket may be composed of an elastic material, e.g. completely composed of an elastic material.

The components of the inventive device may also comprise one or more polymeric materials (e.g. materials with one or more polymers, including for example plastics and/or rubbers and/or foams) and/or metallic materials. Such materials may have the characteristics of flexibility and/or high strength (e.g., being able to withstand strong forces, such as forces exerted thereon in use, without breaking and/or resisting wear) and/or high fatigue resistance (e.g., being able to retain its physical properties over time regardless of the amount used or the environment).

The components of the inventive device may each be constructed of various materials, and may be constructed of the same or different materials, in accordance with embodiments of the present invention. Materials from which any of the device components described herein may be constructed include, but are not limited to: polymeric materials, e.g. photopolymer materials such as Tangoplus ^TM And Verocleir ^TM And/or plastics, e.g. polytetrafluoroethylene or Polytetrafluoroethylene (PFTE), including expanded polytetrafluoroethylene (e-PFTE), polyester (Dacron) ^TM ) Polypropylene, nylon, polyethylene, high Density Polyethylene (HDPE), polyurethane, and the like, metals and metal alloys such as chromium, titanium, stainless steel, and the like. In various embodiments, such materials may be or include one or more thermoplastic materials. Such materials may include acrylonitrile-butadiene-styrene (ABS) C3Olefinic acids, such as Polymethylmethacrylate (PMMA), polyoxymethylene (POM), also known as acetal, polyacetal and polyoxymethylene, aliphatic or semi-aromatic Polyamide (PA), polyethylene (PE), polypropylene (PP), polyetheretherketone (PEEK), cyclic Olefin Copolymer (COC), cyclic Olefin Polymer (COP), polycarbonate (PC) and mixtures thereof.

The material may be transparent or translucent so that a user of the device may view the sample and/or solution throughout the operation of the device (e.g., during mixing or sample processing). By using transparent materials, the fluid is visible when it is transported between one or more chambers of the device, thereby providing visual feedback during operation of the device. Alternatively, some or all of the materials may be opaque so that the device user can view the sample while minimizing contamination from background light.

The material of the device according to an embodiment of the invention may be an effectively injection molded material. The materials employed according to embodiments of the present invention may also be efficiently printed materials, for example, melted and dispensed in an orderly fashion by using a 3D printer. For example, all components may be designed using 3D computer aided design software (SOLIDWORKS) and manufactured using an Objet 260 multi-material 3D printer (Eden Prairie, STRATASYS, mn, usa) according to embodiments of the present invention.

In some embodiments, forming the stator from the stator body material includes performing injection molding of the stator body material. In some embodiments, forming the stator from the stator body material includes embossing, reaction forming, or thermoforming the stator body material. In some embodiments, forming the stator from a stator body material includes three-dimensional (3D) printing the stator. Forming the plurality of channels may include etching or Computer Numerical Control (CNC) machining the stator body material.

In some embodiments, forming the rotor from the rotor body material includes performing injection molding of the rotor body material. In some embodiments, forming the rotor from the rotor body material includes embossing, reaction forming, or thermoforming the rotor body material. In some embodiments, forming the rotor from a rotor body material includes three-dimensional (3D) printing the rotor. Forming the flow passages includes etching or Computer Numerical Control (CNC) machining the rotor body material.

As described above, provided herein are methods of making (e.g., by making) the devices of the invention. In some versions, one or more components of the device are prepared using a manufacturing method, such as injection molding of one or more materials (e.g., plastic). The material (e.g., plastic) may include at least one conventional plastic such as, but not limited to, acrylonitrile Butadiene Styrene (ABS), acrylic, polyoxymethylene (POM), aliphatic or semi-aromatic Polyamide (PA), polyethylene (PE), polypropylene (PP), polyetheretherketone (PEEK), polycarbonate (PC), cyclic olefin polymer, cyclic olefin copolymer, or any other material provided herein.

In some embodiments, the method includes forming a device component body, such as a stator body, a rotor body, or a gasket body. The device component body is a portion of a device that is constructed of a single integrated homogeneous material or combination of materials, or a portion of a device that is constructed of a first material (e.g., a body material). Forming the component body or a portion thereof may be performed by reaction molding, injection molding, embossing, etching, blow molding, rotational molding, thermoforming, and/or machining (e.g., computer Numerical Control (CNC) machining).

The method of the invention may also include forming one or more features in the component, such as microfluidic features. The microfluidic features may be formed in the component body using any of the same methods used in forming the body. For example, the microfluidic features may be formed by performing embossing, injection molding, reaction molding, etching, blow molding, rotational molding, thermoforming, and/or machining (e.g., computer Numerical Control (CNC) machining), or any combination thereof. When the microfluidic features are formed by injection moulding, the container providing the mould comprises one or more interacting microfluidic features around which the molten body material is shaped. This feature remains confined in the resulting body as the molten material becomes solid.

In various embodiments, the method includes operably connecting valve device components, such as stators, rotors, gaskets, and/or porous solid supports, for device operation and/or storage and/or transport. In some versions, the method includes operably connecting the stator and the rotor such that the rotor is configured to rotate about an axis of rotation. Such operative connection may include inserting the rotor into a rotor receiving cavity of the stator. In some aspects, the method includes operatively connecting the seal and the rotor by adhesively attaching the seal and the rotor or by press-fitting or contact-fitting the seal and the rotor together. The method may further include operatively connecting the gasket and the stator by adhesively attaching the gasket and the stator or by press-fitting or contact-fitting the gasket and the stator together.

Make it transportable

In some versions of the rotary valve, in addition to the rotor, stator and retaining element, the valve includes a seal between the stator face and the rotor valve face, and structure for retaining the valve in a storage configuration in which the rotor and stator are spaced apart such that the seal is not compressed at the rotor-stator interface. Gaskets (typically formed of a compressible elastomeric material) tend to compressively deform and adhere to adjacent surfaces if stored under compression for extended periods of time. Thus, preferred embodiments of rotary valves are described herein that include displaceable spacers for preventing a sealing gasket from sealing against at least one of a rotor and a stator, wherein the sealing gasket seals the rotor and the stator together in a fluid tight manner when the spacers are displaced. In this storage configuration, the gasket is not deformed by forces exerted thereon and therefore does not undergo permanent deformation or undesirable rotor or stator adhesion, which may affect the effectiveness of the valve.

One aspect of the present invention provides a rotary valve comprising (a) a rotor 10, the rotor 10 comprising a rotor valve face 12 and an axis of rotation 16; (b) a stator 50; (c) a gasket 80 interposed between the stator and rotor valve faces; and (d) a displaceable spacer 60 for preventing the sealing gasket from sealing against at least one of the rotor and the stator, wherein the sealing gasket is configured to facilitate achieving a fluid-tight interface between the rotor and the stator when the spacer is displaced. In certain embodiments, the valve further comprises a retaining element 90, the retaining element 90 biasing the rotor and the stator towards each other.

A displaceable spacer according to an embodiment of the invention is an aspect configured for preventing a sealing gasket from sealing against at least one of a rotor and a stator. When the spacer is displaced, for example from a pre-activated configuration to an activated configuration, the sealing gasket seals the rotor and stator together in a fluid-tight manner. According to an embodiment of the invention, the displaceable spacer may be part of and/or integral with the stator or rotor.

In one embodiment, in the storage configuration, the displaceable spacer comprises a plurality of tabs that contact a lip on the rotor to hold the rotor away from the stator. In the operative configuration, each of the plurality of tabs is displaceable to disengage from the lip. In one embodiment, the displaceable spacer 60 comprises a plurality of tabs that are displaceable from a first tab configuration to a second tab configuration. Fig. 8A-8B illustrate one embodiment of a valve in a storage position. The stator includes a plurality of vanes. In this embodiment, the stator includes a plurality of fins 61. In this embodiment, a subset of the plurality of vanes are arranged around the periphery of the rotor-stator interface, i.e., peripheral vanes 62. The remaining fins are placed to interface internally at the end of the rotor, i.e. the inner fins 63. The displaceable spacer may comprise a peripheral flap, an inner flap or a combination of both an inner flap and a peripheral flap.

The displaceable spacer (e.g., flap) may be substantially shaped as a three-dimensional box or rectangular shape. Each of the spacers (e.g., tabs) may include a flat face for contacting a lip of a rotor provided herein in a pre-activated configuration. Such a plane may be perpendicular to a plane defined by the stator face and/or the rotor valve face. Such a flat face may be configured to exert a force on the rotor lip in a direction parallel or substantially parallel to the axis of rotation of the rotor.

The displaceable spacer may be constructed of any of the same materials as the stator, rotor, or other device components provided herein. For example, in various embodiments, the displaceable spacer is constructed of a polymeric material, such as plastic, and may be integral with the stator body. As such, in some cases, the stator may include a main body and one or more displaceable spacers operably coupled to and/or integral with the main body.

In various aspects, a rotor suitable for use in a storable rotary valve includes at least one lip 21 to interact with a plurality of tabs 61 that are displaceable from a storage configuration to an operating configuration, wherein each tab 61 contacts the at least one lip 21 to prevent the sealing gasket from sealing against the rotor and stator in the storage configuration and to disengage the tab from the at least one lip when the tab is displaced from the storage configuration to the operating configuration. In one embodiment, the rotor comprises a curved outer wall comprising at least one lip. Such peripheral lip 22 is configured to engage with a plurality of peripheral flaps. In some embodiments, for example, as shown in fig. 8B and 9B, the rotor may include a lip, i.e., an inner lip 23, within the body of the rotor, and the rotor further includes a displacer slot 28 adjacent the inner lip for each of the plurality of vanes 63, the displacer slot 28 being a negative space (negative space) within the body of the rotor capable of receiving the vane when displaced to the operating configuration.

According to various embodiments, each flap contacts the at least one lip, thereby preventing the sealing gasket from sealing the rotor and the stator in a first flap configuration and disengaging from the at least one lip when the flap is displaced from the first flap configuration to a second flap configuration. In a second wing configuration, the sealing gasket seals in a fluid-tight manner against the rotor and/or the stator.

To facilitate displacement of the spacer when transitioning from the storage configuration to the operating configuration, the rotor may include one or more cams 24 adjacent the lip that interact with the displaceable spacer. Each cam may be a ramp that acts to displace the spacer as it rotates. For embodiments in which the stator includes a plurality of peripheral fins, each cam has a length and tapers along its length from a first radial distance from the axis of rotation of the rotor to a second radial distance greater than the first radial distance. As such, each cam may be a ramp that gradually slopes radially outward from, for example, the axis of rotation of the rotor along the circumference of the rotor or a portion thereof. In such embodiments, the one or more cams exert a force on the displaceable spacer (e.g., the plurality of vanes) in an outward or substantially outward direction (e.g., in a direction away from the rotational axis of the rotor) as the rotor rotates. Typically, the second radial distance is equal to or exceeds the distance of the outermost edge of the lip from the main body of the rotor. Fig. 2B and 2C show an embodiment of the rotor in which the cam has a length that is sloped from a distance inside the outer edge of the lip to a distance flush with the edge of the peripheral lip.

For embodiments in which the stator includes a plurality of inner fins, each cam has a length and tapers along its length from a first radial distance from the axis of rotation of the rotor to a second radial distance less than the first radial distance. In various aspects, as the rotor rotates, the one or more cams exert a force on the displaceable spacer (e.g., the plurality of vanes) in an inward or substantially inward direction (e.g., a direction toward the rotational axis of the rotor) to actuate the displaceable spacer.

Upon rotation, the tab slides along the ramp of the cam, which thereby displaces the plurality of spacers 60 from the storage configuration to the working configuration, thereby disengaging the plurality of spacers 60 from the at least one lip 21. In one embodiment, the plurality of tabs 61 irreversibly disengage from the at least one lip 21 when the rotor rotates.

As noted above, in various aspects, the valve of the present invention is activatable from a pre-activated shipping or storage configuration to an activated service configuration for receiving one or more fluids therein. Fig. 8A and 8B depict the device in a storage configuration. Fig. 9A and 9B depict the valve embodiment of fig. 8A and 8B in an operating configuration. In the embodiment shown in fig. 8A, 8B, 9A and 9B, the stator includes a plurality of peripheral fins 62 and a plurality of inner fins 63. The peripheral lip 22 of the rotor rests on the peripheral tab 62, while the inner lip 23 rests on the inner tab 63. Thus, in the storage configuration, the rotor is held away from the stator such that the gasket is not compressed at the rotor-stator interface.

Fig. 9A and 9B show the rotary valve in an operating configuration. As described above, after the rotor rotates and the tabs engage the cam, the tabs have deflected beyond the edges of the peripheral and inner lips. The retaining element provides a biasing force in the form of two wave springs 96. The biasing force presses the rotor against the stator to create a fluid-tight seal at the rotor-stator interface.

In various embodiments, one or more displaceable spacers (e.g., a plurality of tabs) or other structures configured to hold the rotary valve in the storage state are irreversibly disengaged from the at least one lip or other corresponding structure as the rotor rotates. In such embodiments, the rotor is actuated in a direction along the axis of rotation towards the stator when the displaceable spacer is displaced. However, the biasing element prevents the rotor from actuating in the opposite direction away from the stator. In this way, once the valve device is activated as described herein, it cannot be reversibly inactivated to be held in the storage/transport position again, for example, by rotating the rotor (e.g., rotating the rotor in a direction opposite to the direction in which it is rotated to activate the valve device). Thus, once the stator is sealed in a fluid-tight manner with the seal and/or the rotor, it will not unseal during operation or subsequent use of the device. Thus, the device is discarded after use (e.g., by flowing one or more fluids (e.g., liquids, such as a sample) therethrough), rather than being stored or transported again in a transport location. Thus, embodiments of the valve devices disclosed herein are single use devices, where single use refers to a single use period that is not disturbed by long storage (e.g., storage for 1 day or more, or 2 days, 5 days, 10 days, 20 days, or 50 days or more, 180 days or more, or 365 days or more) and/or transportation of the device.

In various aspects, the valve of the present invention utilizes a different structure than the flap embodiment shown in fig. 8A, 8B, 9A and 9B to transition from a pre-activated shipping or storage configuration to an activated configuration for operation of the device. In such embodiments, the rotor may be operably connected to the stator by a pin and rail coupling. In such an attachment, the rotor includes one or more pins that move in a guide track in the stator such that the rotor remains away from the stator in the storage position and then disengages the guide track as the rotor rotates. In another embodiment, the stator includes one or more pins that move in guide tracks in the rotor as the rotor rotates. The rotor may also be operatively connected to the stator by a thread and groove coupling, wherein the rotor includes one or more threads that matingly connect to one or more reciprocating grooves on the stator. Optionally, the stator comprises one or more threads matingly connected to one or more reciprocating grooves on the rotor. In such an embodiment, the biasing element will assist in disengaging the rotor from the pin-track or threaded structure to form a fluid-tight seal and prevent the valve from transitioning back to its storage configuration.

In some embodiments, in addition to using a pin and track or pin and guide arrangement, the rotary valve utilizes a pin and groove arrangement between the rotor and stator to transition from a pre-activated or storage state to a sealing gasket engaged and ready to use state. The pins are located within the grooves or guide structures during storage or during transport. Then, in preparation for use of the valve, the rotor is moved into engagement with the stator to seal the gasket to the stator valve surface. This movement from the storage state may be guided by one or more guide structures. The guide structure may include a guide that interfaces with one or more interfaces or pin structures. For example, the rotor may include one or more interfacing structures (e.g., pins) adapted to engage with complementary guides, rails, or tracks associated with the stator.

Optionally, the stator may include guides that engage one or more interfacing structures associated with the rotor. In either configuration, the interaction between the docking structure and the guide may guide the relative movement of the rotor and stator during transition from the storage/storage state and the gasket sealing/ready-to-use state. It will therefore be appreciated that the shape of the guide formation in combination with the relative movement of the rotor-stator will control the manner in which the gasket engages the stator valve surface during the transition. For example, the rotor may rotate such that the stator guide structure guides the rotor downward into engagement with the stator. In various embodiments of this alternative configuration, the rotary valve may include 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more interfacing structures. The docking structure may include, but is not limited to, pins, pegs, posts, nails, hooks, and locks. Depending on the particular configuration, the docking structure may be used on either the rotor or the stator. Furthermore, the relative movement of the rotor-stator is also controlled by the guides. The guide may guide the relative motion such that when the rotor moves in one direction (e.g., rotationally), the guide also causes relative movement between the rotor-stator in another direction (e.g., downward or decreasing relative movement of the gasket-stator spacing). This guiding results in the desired contact between the sealing gasket and the stator. A rotary valve of this configuration may include 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or more guides. Guides may include, but are not limited to, rails, tracks, grooves, and grooves. The guides and interfacing structures for the rotor-stator combination are complementary.

Furthermore, and in addition to the advantageous long-term storage capabilities of the rotary valve embodiments described herein, it should be appreciated that rotary valves having complementary interfacing structures and guides as described above may remain engaged in a stowed condition for extended periods of time.

One aspect provides a method of storing a rotary valve, the method comprising: (ii) (a) placing a valve as described herein into a storage vessel; and (b) storing the valve for a period of time. In some embodiments, the storing of the valve includes maintaining the valve in a storage position with the gasket spaced apart from at least one of the rotor and the stator. In some embodiments, the rotor includes a seal, and in the storage configuration, the seal is spaced apart from the stator. In some embodiments, the stator includes a gasket, and in the storage configuration, the gasket is spaced apart from the rotor. The method may comprise placing the valve in a storage location, such as within a storage container and/or on a tray or shelf, and then storing the valve device for a period of time. The storage container may comprise, for example, a bag, a box (e.g., an open-top box), a plastic mold, or another component having a recess for receiving the valve or a portion thereof. The storage vessel may also be an intermodal container, which is a ship or train cargo transport vessel, or a room such as a room of a storage facility. Multiple valves may be stored in the same container.

In various embodiments, the method includes storing the valve device for a period of time, such as in a storage location. The period of time may range, for example, from 1 day to 2 years, such as 10 days to 1 year, such as 30 days to 300 days. The period of time may be 1 day or longer, 30 days or longer, 90 days or longer, 180 days or longer, 1 year or longer, or 2 years or longer. The period of time may also be 1 day or less, 30 days or less, 90 days or less, 180 days or less, 1 year or less, or 2 years or less. The period of time may range, for example, from 1 month to 24 months, such as from 10 months to 20 months, such as from 12 months to 18 months. The period of time may be 6 months or longer, such as 9 months or longer, such as 12 months or longer. The period of time may also be 6 months or less, 9 months or less, 12 months or less, 15 months or less, 18 months or less, or 24 months or less. In such embodiments, the months are consecutive months.

Some embodiments of the rotary valve described herein provide long term storage or reliable shelf life. In some aspects, a structure is provided that maintains a desired spacing between the rotor and the stator during storage. Thus, during storage, the rotor and stator, and any interposed gaskets, are maintained in a spaced or non-fluid tight relationship. The conversion from storage to ready-to-use or establishing a fluid-tight relationship is accomplished by relative movement between the rotor and stator. Fig. 8A, 8B illustrate the use of a displaceable spacer 60 (e.g. one or more tabs 61) to hold the rotor and stator in storage. The stator rotates and deflects the fins, allowing for sealing between the rotor and stator. Fig. 10A-12B illustrate in detail the configuration and use of a threaded rotor that remains in storage and transitions to a fluid seal between the rotor and stator. In addition to these configurations and methods, additional configurations and methods may be used to maintain the rotary valve in the storage state as described herein.

Rotary valve with threaded rotor-stator engagement

In some embodiments of the rotary valve, the storage state is maintained by a threaded feature between components of the rotary valve. In some embodiments, a threaded relationship exists between a threaded portion of the rotor and another threaded component of the rotary valve. Fig. 10A, 10B, and 10C show perspective, side, and cross-sectional views of a rotary valve having a threaded rotor.

Fig. 11A, 11B, 12A and 12B illustrate an embodiment of a rotary valve having a threaded engagement between a portion of the rotor 10 and the retaining ring 91. Fig. 11A and 11B illustrate perspective and cross-sectional views, respectively, of an embodiment of a rotary threaded valve in a storage state. Fig. 12A and 12B show a perspective sectional view and a cross-sectional view, respectively, of the embodiment of the threaded rotary valve of fig. 11A, 11B out of storage due to relative movement between the threaded members. The rotary valve in each of the views of fig. 11A-12B is similar to the rotary valve of fig. 4.

As best seen in fig. 11A, the retaining ring 91 includes a threaded portion 191. In the illustrated embodiment, the threaded portion 191 includes threads 194. The rotor 10 comprises an outer wall 11 having a threaded portion 110. In the illustrated embodiment, the threaded portion 110 includes a recess 114 corresponding to the threads 194. In the stowed configuration shown in fig. 11A and 11B, the biasing element 96 maintains engagement between the threads 194 and the groove 114, helping to maintain the desired clearance between the rotor sealing surface (the gasket 80) and the stator valve face 52. As best seen in fig. 11B, the top of the rotor cover 30 is substantially flush with the upper surface of the retaining ring 91, maintaining a low profile rotary valve design factor. Rotation of the rotor relative to the retaining ring 91 moves the rotor toward the stator and into the operating condition shown in fig. 12A and 12B. In this view, the disengagement from storage is clear as the rotor cover is recessed below the top surface of the retaining ring and the gasket 80 provides a fluidic seal between the rotor and stator. It can also be seen in fig. 12B that the rotor is separated from the threaded portion 194 of the retaining ring 91. Movement of the threaded rotor to this position ensures that the rotor is free to index relative to the stator as described herein.

With reference to fig. 11A-12B, a rotary valve is provided that includes a rotor 10 having an axis of rotation 16, a rotor valve face 12, and an outer face 13 opposite the rotor valve face. In addition, the stator 50 has a stator valve face 52, the stator valve face 52 being positioned opposite the rotor valve face. The rotary valve further comprises a retaining element 90, the retaining element 90 biasing the rotor and the stator towards each other, the retaining element 90 comprising a retaining ring 91 and a biasing element 96. The rotary valve is maintained in the storage state when the threaded portion of the retaining ring engages the threaded portion of the rotor. In one configuration, the relative movement between the rotor and the stator creates a fluid tight arrangement between the rotor valve surface and the stator valve surface, or is rotation of the rotor, moving the rotor along the threaded portion of the retaining ring until released to seal against the stator. In this way, a rotary valve having a threaded rotor for engagement in a storage state may be configured to transition to provide a fluid-tight seal within the rotary valve by less than one, half, quarter, or eighth revolution of the threaded rotor. Still further, it should be appreciated that the gasket disposed between the rotor valve face and the stator valve face does not form a fluid tight seal with the stator valve surface when the threaded members of the threaded rotary rotor valve are engaged.

With respect to the various views of the rotary valves of fig. 13-16, each rotary valve is a rotary valve of similar configuration to the other rotary valves described herein. Each rotary valve relates to a rotary valve having a rotor 10, the rotor 10 having an outer face 13 and a rotor valve face 12 facing away from the outer face 13. There are a pair of

holes

41, 42 through the rotor valve face 12. The stator 50 has a stator face 52 with a plurality of stator ports 53 therein. Each of the plurality of stator ports 53 communicates with a fluid passage 54. Additionally, in some configurations, a gasket 80 is interposed between the stator face 52 and the rotor valve face 12. Within the seal 80 are a pair of openings 83 which are aligned with the pair of

apertures

41, 42. When in the storage state, the sealing gasket is spaced from the stator face 52, and when released from the storage state, the sealing gasket is held in fluid-tight relationship with the stator face by the retaining element 90.

FIG. 13 is a partial cross-sectional view of the rotary valve in a storage state. In this embodiment, there is a spacer 180 between the rotor and the stator. In one embodiment, the spacer 180 is located between the gasket 80 and the stator valve surface. The spacer 180 may be configured as a disc or o-ring that is formed integral with the gasket 80 or attached to the gasket 80. Additionally, the spacer 180 may be disposed along the gasket sealing surface such that the spacer 180 (a) maintains a gap between the gasket sealing surface and the stator surface and (b) places the rotary valve in a storage state. In one aspect, a rotary valve adapted for use with the spacer 180 is released from a storage state by relative movement between the rotor and the stator sufficient to displace the spacer to allow engagement between the gasket sealing face and the stator face.

Fig. 14A and 14B illustrate perspective views of a rotary valve having a slotted rotor in a storage state (fig. 14A) and a sealed/ready to use state (fig. 14B). Fig. 14A illustrates the rotor in a storage state. A plurality of slots 112 and angled features 114 are disposed about the rotor outer wall 14. The retaining ring 91 includes a corresponding groove 116 that engages the outer wall of the rotor. As shown in the view of fig. 14A, the rotary valve is maintained in the storage state by engagement between the groove 116 and a portion of the ramp feature 114. Rotation of the slot rotor causes the rotor to transition from the storage state in fig. 14A to the sealed/ready-to-use state shown in fig. 14B. With this configuration, a retaining ring 91 is illustrated surrounding the rotor 10 and coupled to the stator. The retaining ring 91 has a plurality of grooves 116 around a portion of the retaining ring adjacent the rotor 10. Further, the rotor is configured to have a plurality of complementary shapes that mate with a plurality of grooves in the retaining ring, as best shown in fig. 14A. The rotary valve is maintained in the storage state due to the engagement of the plurality of recesses with the plurality of complementary shapes. The rotary valve is released from the storage condition shown in fig. 14A by relative movement between the rotor and the retaining ring sufficient to disengage the plurality of grooves around a portion of the retaining ring from the mating plurality of complementary shapes on the rotor. As a result of this relative movement, the rotary valve is switched, typically by rotation, to the sealing/ready to use configuration shown in fig. 14B.

FIG. 15 is an exploded view of the rotary valve with the rotor spaced above and outside the retaining ring. Similar to the screw cap rotor of fig. 11A-12B, the rotor of fig. 15 engages complementary threaded portions in the rotor and retaining ring to provide a storage state and simple disengagement from the storage state. The rotor 10 includes a ridge 118 and a space 119 along the outer wall 14 adjacent the upper circumference of the rotor. The ridges and spaces together form a complete circumference around the rotor. In this embodiment, as shown, there are pairs of ridges 118 and spaces 119 that alternate with each other. A similar configuration exists on the retaining ring 91. The retaining ring 91 includes complementary ridges 195 and spaces corresponding to the ridges and spaces on the rotor. When in the storage state, the ridges 118 of the rotor engage the ridges 195 of the retaining ring to maintain the spacing between the rotor and the stator. A quarter turn of the rotor will move the rotor ridges 118 into the gaps in the retaining ring and the rotor will drop to a sealed condition and be ready for use. Accordingly, the embodiments relate to a rotary valve having a retaining ring surrounding a rotor and coupled to a stator. The retaining ring has a pair of arcuate shapes along a surface adjacent the rotor, and the rotor has a complementary pair of arcuate shapes corresponding to the pair of arcuate shapes in the retaining ring. The rotary valve maintains the storage state during engagement between the pair of arcuate shapes and the complementary pair of arcuate shapes of the rotor and the retaining ring. The rotary valve as constructed in fig. 15 is released from the storage state by relative movement between the rotor and the retaining ring sufficient to disengage a pair of arcuate shapes along the surface adjacent the rotor from a complementary pair of arcuate shapes on the rotor.

FIG. 16 is a bottom cross-sectional view of a clamp for holding the rotary valve in a storage state. The clip 197 includes a pair of

prongs

198, 199, the

prongs

198, 199 being located within the rotary valve to maintain the desired gap between the stator and rotor. As shown in fig. 16, the rotary valve includes a clip 197 that engages the rotary valve to maintain a gap between the gasket sealing surface and the stator surface. The portion of the rotary valve supported by the

prongs

198, 199 maintains this rotary valve embodiment in the storage state. When the clip 197 is removed, the rotary valve of fig. 16 is released from storage. Removal of the clip 197 allows the retaining element to move the sealing gasket into fluid tight relationship with the stator face.

Fig. 17A-17E and 18A-18C provide various alternative configurations of flow passage spacers within the solid support chamber 46. The fluid flow within the chamber 46 depends on many factors, such as the type of solid support 45 and the function performed in the chamber 46 or the overall function of the rotary valve embodiment. The flow passage spacers may help ensure that the fluid flows through the chamber 46, and through the solid support 45 within the chamber 46 and around the solid support 45 within the chamber 46. Thus, a range of different flow path spacer configurations may be advantageously employed to enhance the function and performance of the rotary valve.

Fig. 3B illustrates a version of the flow path spacer 49 configured in a raised configuration above the bottom 39 of the solid support chamber 46. The bottom 39 in this embodiment is flat, but a sloped chamber bottom may be used in other configurations described herein. In this embodiment, the flow passage spacer 49 has an arcuate shape corresponding to the general curvature of the inner wall of the solid support chamber 46. The flow passage partition 49 is separate from both the wall of the chamber 46 and the outlet 48 of the chamber 46. Other flow passage partition shapes, orientations, and indoor configurations (within chamber configurations) are also possible. The protruding flow path spacer variation includes: (a) The flow path spacers may be segmented rather than continuous structures; (b) The flow path spacer may include one or more structures along a surface (e.g., a sidewall or bottom 39) of the solid support chamber; (c) The flow path divider may be spaced from the chamber outlet 48 or terminate at the edge of the outlet 48; and (d) the flow path spacer may be raised above, recessed within, an interior surface (e.g., bottom or sidewall) of the chamber. These and other flow path spacer 49 and chamber 46 configurations-including various combinations of one or more embodiments-are further described in fig. 17A-18C.

Fig. 17A-17E illustrate views of the flow chamber 46 with a plurality of flow passage spacers 49 arrayed around the carrier chamber outlet 48. Fig. 17A is a top view of the solid support chamber 46 as shown in fig. 3B with three raised flow passage partitions 49 arranged in a radial pattern around the support chamber outlet 48. Each flow path partition 49 begins at the carrier chamber outlet 48, extends along the chamber bottom 39, and terminates before reaching the side walls of the chamber 46. Fig. 17B is a cross-sectional view of the solid support chamber 46 in fig. 17A. This view clearly shows that the chamber bottom 39 is flat and the flow path spacers 49 are aligned with and terminate at the flow path exit 48, thereby being spaced from the chamber sidewalls. Fig. 17C is a cross-sectional view of the solid support chamber 46 similar to fig. 17B. Similar to fig. 17B, the embodiment of the flow channel partition 49 in fig. 17C shows that the chamber bottom 39 is flat and the flow channel partition 49 aligns with and terminates at the flow channel outlet 48, thereby providing a separation from the chamber sidewall. Fig. 17C illustrates an angled or wedge-shaped flow path spacer 49. In this embodiment, a wedge or sloped flow passage spacer is used in conjunction with a flat chamber bottom 39. In this embodiment, the flow passage partition 49 has a height above the chamber bottom 39 that is smaller near the chamber outlet 48 and greater away from the chamber outlet 48. Fig. 17D is a cross-sectional view similar to fig. 17B and 17C, wherein the flow path spacers 49 are aligned with the flow path exits 48 and terminate, thereby providing a spacing from the chamber sidewalls. Fig. 17D illustrates a sloped chamber bottom 39. The sloped chamber bottom 39 may be used alone, as in the absence of any flow path spacers 49, or with any of the flow path spacer embodiments described herein. In the illustrative embodiment of fig. 17D, a sloped chamber bottom 39 is used in conjunction with a sloped or wedge-shaped flow path spacer 49. In contrast to the sloped or wedge-shaped flow path spacer of FIG. 17C, the flow path spacer embodiment illustrated in FIG. 17D is sloped to have a greater height near the chamber outlet 48 and a lesser height nearest the sidewall. In one aspect, as is clear from the cross-sectional views of fig. 17B, 17C, and 17D, the flow passage spacer 49 may appear rectangular (fig. 17B), triangular (fig. 17D), or trapezoidal (fig. 17C) in cross-section. Fig. 17E illustrates a top view of the solid support chamber 46, the solid support chamber 46 having a plurality of flow path partitions 49 similar to the flow path partitions in fig. 17A, wherein the flow path partitions are arranged along the chamber bottom 39 and arrayed around the chamber outlet 48, and spaced from the chamber sidewalls. The embodiment of the flow path divider 49 in fig. 17E illustrates the location of the flow path divider spaced from both the chamber sidewalls and the chamber outlet 48. The flow passage spacer 49 shown in this configuration may also be modified to other configurations as described above with reference to fig. 17A-17D.

Fig. 18A-18C illustrate views of the flow chamber 46 having a plurality of flow passage partitions 49 arrayed around the carrier chamber outlet 48, similar to those described above with respect to fig. 17A-17D, directly adjacent the chamber outlet 48 and terminating spaced from the chamber sidewall. The embodiment of fig. 18A-18C illustrates the flow passage spacer 49 recessed into the chamber bottom 39. Fig. 18A is a top view of a recessed flow path spacer 49 adjacent the chamber outlet 48. Fig. 18B is a cross-sectional view of the carrier chamber 46 in fig. 18A. The view of fig. 18B illustrates the flat bottom of the flow passage spacer 49. In the alternative to the flat-bottom recessed flow path spacer of fig. 18B, fig. 18C is a cross-sectional view of the carrier chamber 46 with a recessed flow path spacer of an angled or wedge shape. In the illustrated embodiment, the sloped recessed flow path divider is deeper nearer the chamber outlet 48 and shallower nearer the chamber sidewall. In other alternative embodiments, the recessed flow path spacers are configured similar to the various embodiments of the slope, shape of the flat and sloped chamber bottoms described with respect to fig. 17A-17D, or may be optionally spaced from the chamber outlet 48, as shown in fig. 17E.

It will be appreciated from the above disclosure that the use of flow path spacers in rotary valve embodiments provides a wide variety of carrier chamber 46 configurations to accommodate a wide range of different possible solid carrier 45 embodiments and the desire for robust rotary valve functionality. Thus, the solid support chamber 46 may have a flat or sloped chamber bottom 39 without any flow path support. This flat chamber bottom 39 is illustrated in fig. 4 without the flow channel carrier. In this configuration, the solid support 45 rests on the flat or sloped chamber bottom 39. Optionally, the solid support chamber 46 may include one or more flow passage spacers 49, as illustrated and described in fig. 3A, 3B, 17A-18C. Additionally or alternatively, various flow passage spacer embodiments may be raised above the flat or sloped chamber bottom 39 or recessed into the flat or sloped chamber bottom 39. Furthermore, it should be understood that these various combinations of carrier chambers and flow path dividers may be further combined to enhance the operation and function of the rotary valve. In rotary valves having more than two, three, four or more solid support chambers 46, each of the support chambers may have the unique configuration and flow path divider characteristics of the elements of the chamber bottom described above. In other words, each of the solid support chambers and their respective flow paths 40 can be configured based on a unitary rotary valve function. Fig. 18A provides an exemplary embodiment of one such combination, wherein one solid support chamber 46 includes convex arcuate flow path spacers 49, while the other chamber 46 illustrates an array of concave flow path spacers 49. It should be understood that all of the various variations of the flow path partition, solid support chamber, and support chamber bottom described herein may be combined and modified as desired based on the type of solid support 45 used and the overall rotary valve function and performance.

Rotary valve working examples

The table in fig. 19 depicts a series of sample processing steps that may be used to prepare a biological sample for bioassay analysis using the rotary valve 00 of fig. 1A-1B 2. Fig. 20A-30C depict a valve sequence using a rotary valve 00 with a gasket 80 configuration as shown in fig. 7B 1. The following examples illustrate various functions that may be performed by each of the hole shapes formed in the gasket to establish fluidic communication between different ports 53 on the stator 50. In the following figures, the larger area of the strip 171 represents the entire rotor-stator interface, while the smaller rectangles 172 located within the strip represent locations along the stator face 52 that can support the ports 53. The circles on the smaller rectangles 173 indicate the locations of the actual ports present in the stator 50. All other shapes on the strip represent gasket features, as shown in fig. 7B1, with corresponding reference numerals. These various gasket features serve to provide a wide variety of flow control communication with the ports 43 on the stator 50, as will become apparent from the description below.

Step 1:	position of
		0	(Storage)
1	Original
		2	Sample loading
3	Dissolving/mixing
		4	Binding of sample to matrix
5	Substrate washing
		6	Drying of the substrate
7	Analyte elution
		8	Reagent mixtureIn 1. Sup. Th
9	Reagent mix-2
		10	Augmented wellbore filling

In fig. 20 to 30, the following notation will be used. The graph labeled "a" depicts the rotor-stator interface available during a valve sequence, appearing as if the circumference of the rotor-stator interface were expanded to form a straight line. The graph labeled "B" depicts the rotor-stator interface available during the valve sequence as viewed from the rotor outer face 13. The graph labeled "C" describes which ports are pressurized and to which measurements.

Fig. 20A-20B show the rotary valve in its storage configuration, wherein the seal 80 is prevented from sealing against at least one of the rotor 10 or the stator 50. FIG. 20C shows no pressure being applied and all pneumatic sources P1-P4 are open to exhaust.

Fig. 21A-21B illustrate the rotary valve first indexed from the storage configuration to the operating configuration to form a fluid-tight seal between the stator 50 and the rotor 10. The fluid tight seal is the result of the gasket shown in fig. 7B1 being compressed between the stator face 52 and the rotor valve face 12. As seen in fig. 21C, no pressure is applied to the system and all pneumatic sources are blocked in the home position.

Fig. 22A-22B show the situation when the rotary valve is indexed to load the biological sample and lysis buffer. Pneumatic source P1 is pressurized to cause the sample to flow from the sample port to the Sample Holding Chamber (SHC) port via first connector groove 86 a. The first connector groove 86a allows a port located at a greater radial distance to be in fluid communication with another port located at a lesser radial distance along the same radial line. The first connector groove 86a enables the sample to be reoriented on the stator 50. Similarly, source Cr is pressurized to flow lysis buffer from its source (LB) to the lysis buffer holding chamber via second connector groove 86 b. The second connector groove 86b connects the lysis buffer port with the Lysis Buffer Holding Chamber (LBHC) port, which are located at two different distances along the same radial line in the stator 50. For ports that are not actively in communication with the gasket bore (i.e., wash buffer port and waste port), the gasket 80 seals against all ports that are not currently actively being used. Only the ports in active communication with the gasket holes can move fluid between ports in the stator 50. FIG. 22C shows the pneumatic source P1 and Cr turned on and pressurized to 5.0psig.

Fig. 23A-23B show the rotary valve in its dissolving/mixing position. The pneumatic source P2 is pressurized to flow the sample from the sample holding chamber and the lysis buffer from the lysis buffer holding chamber into the lysis mixing chamber. The radial connector groove 99a is used to connect the sample holding port, lysis buffer holding port and lysis mixing chamber port together. The radial connector grooves 99a allow multiple ports in the stator 50 along one radial path but along different radial lines to be in fluid communication with each other. This allows sample and lysis buffer to flow under pressure from their respective holding chambers through the lysis mixing chamber port and into the mixing chamber (LBXC). FIG. 23C shows pneumatic source P2 turned on and pressurized to 5.0psig. Pneumatic sources P1, P3, and P4 are exhausting to atmosphere, while pneumatic source Cr is blocked.

Fig. 24A-24B illustrate the rotor in position to load a dissolved sample onto the substrate. Pneumatic source P1 is pressurized to push the lysed sample from the lysis mixing chamber (LBXC) through a lysis mixing chamber port aligned with gasket inlet 84. As the dissolved sample passes through the porous solid support 45 in the solid support chamber 46. The target analyte binds to the porous solid support 45, while the remaining portion of the lysed sample (e.g., cell debris) flows out of the flow cell outlet through the gasket outlet 85 and is directed to a waste collection element ("waste") through a waste port located in the stator 50. FIG. 24C shows pneumatic source P1 pressurized to 20.0psig. The pneumatic sources P2 and Cr are blocked. Pneumatic sources P3 and P4 are exhausting to atmosphere.

Fig. 25A-25B show the rotary valve in its substrate washing position. The rotor has moved to connect the Wash Buffer (WB) port to the waste port through a flow cell holding a matrix that was previously loaded with the target analyte. The pneumatic source is changed from P1 to P2 to push the wash buffer through the wash buffer port aligned with the gasket inlet 84. The wash buffer flows over the porous solid support 45 to remove unwanted contaminants while the target analyte remains bound to the porous solid support 45. The contaminant-laden wash buffer exits the flow cell outlet through the gasket outlet 85 and is directed to a waste collection element through a waste port located in the stator 50. FIG. 25C shows pneumatic source P2 pressurized to 20.0psig. The pneumatic sources P1 and Cr are blocked, and the pneumatic sources P3 and P4 are exhausting to the atmosphere.

Fig. 26A-26B illustrate the situation when the rotary valve 10 is indexed to the substrate drying position. The porous solid support 45 is subjected to an air drying step to remove residual wash buffer from the solid support chamber 46. A pneumatic pressure source P2 is applied to the air port through the gasket inlet 84. The air passing through the solid support chamber 46 then exits the flow chamber outlet through the gasket outlet 85 and is directed to a waste collection element through a waste port located in the stator 50. FIG. 26C again shows that pneumatic source P2 is pressurized to 20.0psig. The pneumatic sources P1 and Cr are blocked and the pneumatic sources P3 and P4 are exhausting to atmosphere.

Fig. 27A-27B show the rotary valve indexed to elute a matrix for eluting an analyte from the porous solid support 45. The pneumatic source P3 is pressurized to send water or other eluent through the water port into the gasket inlet 84. Water flows through the porous solid support 45 in the solid support chamber 46 to release the target analyte from the solid support. The eluate containing the target analyte exits the solid support chamber 46 from the flow chamber outlet through the gasket outlet 85 and enters the positive sample metering path ("Pos MC") via the positive sample metering path port in the stator 50.

At the same time, the pneumatic pressure source P3 pressurizes the negative water port to move water (i.e., the negative control sample) to the negative metering channel port. This additional water port was used to load the negative control for the assay being performed. A third selector recess 86c in the gasket allows the water port and the negative control metering passage ("Neg MC") port to be in fluid communication, filling the negative metering passage. FIG. 27C shows the pneumatic sources P1, P2 and Cr being blocked. Pneumatic source P3 is pressurized to 5.0psig and pneumatic source P4 is vented to atmosphere.

Both fig. 28 and 29 illustrate the rotary valve in its reagent mixing position, but the rotary valve will work differently due to the different pneumatic sources being activated or de-activated. In fig. 28A-28B, the rotary valves flowed the positive and negative samples from each respective metering pathway to separate positive and negative mixing chambers ("Pos XC" and "Neg XC", respectively). Pneumatic source P4 pressurizes the positive metering access port to transfer the positive sample through first selector groove 87a into the positive mixing chamber. The first selector recess 87a allows fluid communication between a port at a first radial distance from the axis of rotation along one radial line and a port at a second and smaller radial distance from the axis of rotation along a different radial line. At the same time, the pneumatic source P4 pressurizes the negative metering access port to transfer the negative sample through the second selector recess 87b into the negative mixing chamber. FIG. 28C shows that the pneumatic sources P1, P2 and Cr are blocked. Pneumatic source P3 is vented to atmosphere and pneumatic source P4 is pressurized to 5.0psig.

In fig. 29A-29B, the rotary valve is held in the same reagent mixing position. After mixing is complete, pneumatic source P3 is pressurized to move fluid back into each of the respective metering passageways. The first selector recess 87a allows fluidic communication between the positive mixing chamber port and the positive metering passage port to fill the positive metering passage. Likewise, the second selector recess 87b allows fluidic communication between the negative mixing chamber port and the negative metering passage port to fill the negative metering passage. FIG. 29C shows that the pneumatic sources P1, P2 and Cr are blocked. Pneumatic source P3 is pressurized to 5.0psig and pneumatic source P4 is vented to atmosphere.

Fig. 30A-30B illustrate the final configuration of the rotary valve, wherein positive samples and negative controls are delivered to the amplification wells. First selector groove 87a now connects the positive metering access port with the positive well port to load the positive amplification well ("Pos Wells"). Although the fluidic path between the positive metering access port and the positive well bore port is shorter than the fluidic path between the positive metering access port and the positive mixing chamber port, the first selector groove 87a again connects the two ports along different radial lines and different radial distances. At the same time, a second selector recess 87b connects the negative metering access port with the negative well ("Neg Wells") port to load the negative amplification well. FIG. 30C shows pneumatic sources P1, P2, P3, and Cr are blocked, while pneumatic source P4 is pressurized to 5.0psig.

When a feature or element is referred to herein as being "on" another feature or element, it can be directly on the other feature or element or intervening features or elements may also be present. In contrast, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features or elements present. It will also be understood that when a feature or element is referred to as being "connected," "attached," or "coupled" to another feature or element, it can be directly connected, attached, or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being "directly connected," "directly attached" or "directly coupled" to another feature or element, there are no intervening features or elements present. Although described or illustrated with respect to one embodiment, the features and elements so described or illustrated may be applied to other embodiments. One skilled in the art will also recognize that a structure or feature that is disposed "adjacent" another feature may have portions that overlap or underlie the adjacent feature.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and/or "comprising," when used in this specification, specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items and may be abbreviated as "/".

Spatially relative terms, such as "under", "lower", "over", "upper", and the like, may be used herein for ease of description to describe one element or feature's relationship to another element or feature as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is inverted, elements described as "below" or "beneath" other elements or features would then be oriented "above" the other elements or features. Thus, the exemplary term "under" can encompass both an orientation of "on. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, unless specifically stated otherwise, the terms "upward", "downward", "vertical", "horizontal", and the like are used herein for purposes of illustration.

Although the terms "first" and "second" may be used herein to describe various features/elements (including steps), these features/elements should not be limited by these terms unless the context dictates otherwise. These terms may be used to distinguish one feature/element from another feature/element. Thus, a first feature/element discussed below could be termed a second feature/element, and similarly, a second feature/element discussed below could be termed a first feature/element, without departing from the teachings of the present invention.

In this specification and the claims which follow, unless the context requires otherwise, the word "comprise", and variations such as "comprises" and "comprising", will imply that the various elements may be used in combination in the method and article of manufacture (e.g. compositions and apparatus including the methods and apparatus). For example, the term "comprising" will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.

As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as preceded by the word "about" or "approximately" even if the term does not expressly appear. The phrase "about" or "approximately" may be used in describing size and/or position to indicate that the described value and/or position is within a reasonably expected range of values and/or positions. For example, a numerical value may have a value that is +/-0.1% of a specified value (or range of values), +/-1% of a specified value (or range of values), +/-2% of a specified value (or range of values), +/-5% of a specified value (or range of values), +/-10% of a specified value (or range of values), and the like. Any numerical value given herein is also to be understood as encompassing about or about that value unless the context dictates otherwise. For example, if the value "10" is disclosed, then "about 10" is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed, the terms "less than or equal to" the value, "greater than or equal to the value," and possible ranges between values are also disclosed, as is well understood by those skilled in the art. For example, if the value "X" is disclosed, "less than or equal to X" and "greater than or equal to X" (e.g., where X is a numerical value) are also disclosed. It should also be understood that throughout this application, data is provided in a number of different formats and represents a range of endpoints and starting points and any combination of data points. For example, if a particular data point "10" and a particular data point "15" are disclosed, it is understood that greater than, greater than or equal to, less than or equal to, and equal to 10 and 15 and between 10 and 15 are considered disclosed. It is also understood that each unit between two particular units is also disclosed. For example, if 10 and 15 are disclosed, 11, 12, 13, and 14 are also disclosed.

While various illustrative embodiments have been described above, any of several variations may be made to the various embodiments without departing from the scope of the invention as described in the claims. For example, in alternative embodiments, the order in which the various described method steps are performed may generally be varied, and in other alternative embodiments, one or more of the method steps may be skipped altogether. Optional features of various apparatus and system embodiments may be included in some embodiments and not in others. Accordingly, the foregoing description is provided primarily for the purpose of illustration and should not be construed as limiting the scope of the invention as set forth in the claims.

The examples and illustrations contained herein show by way of illustration, and not by way of limitation, specific embodiments in which the invention may be practiced. As mentioned, other embodiments may be utilized and derived therefrom, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein, individually or collectively, by the term "invention" merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept if more than one is in fact disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.

Claims

1. A rotary valve (00), the rotary valve (00) comprising:

a. a stator (50), the stator (50) comprising a stator face (52) and a plurality of channels (54), each channel comprising a port (53) at the stator face;

b. a rotor (10), the rotor (10) being operatively connected to the stator and comprising an axis of rotation (16), a rotor valve face (12) and a flow passage (40), the flow passage (40) having an inlet (41) and an outlet (42) at the rotor valve face, wherein the flow passage comprises a porous solid support (45); and

c. a retaining element (90), the retaining element (90) biasing the stator and the rotor together at a rotor-stator interface (02) to form a fluid-tight seal.

2. Rotary valve according to claim 1, wherein the cross section of the flow passage (40) is non-concentric with the axis of rotation (16).

3. The rotary valve of claim 1, wherein the porous solid support is a polymer.

4. The rotary valve of claim 1, wherein the porous solid support is selected from the group consisting of: silica, diatomaceous earth, ceramics, metal oxides, porous glass, carbohydrate polymers, chitin, zeolites, polyvinyl ethers, polyethylene, polypropylene, polystyrene, nylon, polyacrylates, polymethacrylates, polyacrylamides, and polymaleic anhydride, and any combination thereof.

5. The rotary valve of claim 1, wherein the porous solid support is a membrane.

6. The rotary valve of claim 1, wherein the porous solid support is a hollow fiber.

7. The rotary valve of claim 1, wherein the porous solid support is a fiber.

8. Rotary valve according to claim 1, wherein the rotor valve face (12) comprises a sealing gasket (80) inserted at the rotor-stator interface (02).

9. The rotary valve according to claim 8, wherein the sealing gasket (80) comprises a sealing gasket hole (83) therethrough, and wherein the stator comprises an arc-shaped track (70) for laterally constraining the sealing gasket.

10. Rotary valve according to claim 1, wherein the rotor valve face comprises a fluidic connector (86), wherein in a first rotor position the first port (53 a) of the stator is fluidly connected to the second port (53 b) of the stator via the fluidic connector (86).

11. The rotary valve of claim 10, wherein the first port is located at a first radial distance from the axis of rotation and the second port is located at a second, different radial distance.

12. Rotary valve according to claim 10, wherein in the second rotor position the third port (53 c) is fluidly connected to the fourth port (53 d) via the fluidic connector (86).

13. Rotary valve according to claim 1, wherein the rotor valve face comprises a fluidic selector (87), the fluidic selector (87) having an arc-shaped portion with a centre line arc-shaped equidistant from the rotation axis and a radial portion extending radially from the arc-shaped portion towards or away from the rotation axis.

14. Rotary valve according to claim 13, wherein in a first rotor position a first port (53 a) located at a first radial distance from the rotational axis (16) is fluidly connected to a second port (53 b) located at a second radial distance from the rotational axis via the fluidic selector (87), and in a second rotor position the first port is fluidly connected to a third port (53 c) located at the second radial distance from the rotational axis via the fluidic selector, and wherein the first port remains fluidly connected with the fluidic selector when the rotor rotates between the first and second rotor positions.

15. The rotary valve according to claim 1, wherein the rotor comprises a plurality of flow paths (40), each flow path comprising an inlet (41), an outlet (42) and a porous solid support (45).

16. Rotary valve according to claim 1, wherein the rotor comprises a main body (11) and a rotor cover (30) operatively connected to the main body, and wherein one wall of the flow path (40) is defined by the rotor cover.

17. The rotary valve of claim 1, further comprising a seal (80) between the stator face (52) and the rotor valve face (12), and wherein the stator includes a displaceable spacer (60) for preventing the seal from sealing against at least one of the rotor (10) and the stator (50), and wherein the seal seals the rotor and the stator together in a fluid tight manner when the displaceable spacer is displaced.

18. The rotary valve of claim 1, wherein the retaining element (90) comprises a retaining ring (91) and a biasing element (96).

19. The rotary valve according to claim 18, wherein the retaining ring (91) is fixedly coupled to the stator (50) and the biasing element (96) is a spring biasing the rotor and the stator together.

20. A rotary valve, the rotary valve comprising:

a. a rotor (10), the rotor (10) comprising a rotor valve face (12), an outer face (13) opposite the rotor valve face, and an axis of rotation (16);

b. a stator (50);

c. a gasket (80), the gasket (80) being interposed between the stator and the rotor valve face; and

d. a displaceable spacer (60), the displaceable spacer (60) for preventing the sealing gasket from sealing against at least one of the rotor and the stator,

wherein the gasket seals the rotor and the stator together in a fluid tight manner when the displaceable spacer is displaced.

21. The rotary valve of claim 20, further comprising a retaining element (90), the retaining element (90) biasing the rotor and the stator toward each other.

22. The rotary valve according to claim 21, wherein the retaining element (90) comprises a retaining ring (91) and a biasing element (96).

23. The rotary valve according to claim 22, wherein the retaining ring (91) is fixedly coupled to the stator and the biasing element (96) is a spring.

24. Rotary valve according to claim 20, wherein the rotor (10) comprises at least one lip (21) and the displaceable spacer (60) comprises a plurality of fins (61) displaceable from a storage configuration to an operating configuration, wherein each of the fins (61) contacts the at least one lip (21) thereby preventing the sealing gasket from sealing the rotor and the stator in the storage configuration and each of the fins (61) disengages from the at least one lip when the fins are displaced from the storage configuration to the operating configuration.

25. Rotary valve according to claim 24, wherein the at least one lip (21) is an inner lip (23) and the rotor further comprises a displacer slot (28) adjacent to the inner lip, wherein the displacer slot accommodates an inner vane (63) when the inner vane (63) is displaced to the operational configuration.

26. Rotary valve according to claim 24, wherein the rotor (10) comprises a curved outer wall (14) and the at least one lip (21) is a peripheral lip (22) on the outer wall.

27. Rotary valve according to claim 24, wherein the rotor comprises one or more cams (24), the one or more cams (24) displacing the plurality of fins (61) from the storage configuration to the active configuration upon rotation of the rotor, thereby disengaging the plurality of fins (61) from the at least one lip (21).

28. Rotary valve according to claim 20, wherein the sealing gasket (80) comprises a hole (83) therethrough, and wherein the stator comprises an arc shaped track (70) for laterally constraining the sealing gasket.

29. Rotary valve according to claim 20, wherein the rotor further comprises a flow path (40), the flow path (40) having an inlet (41) and an outlet (42) at the rotor valve face, wherein the flow path comprises a porous solid support (45).

30. A rotary valve according to claim 20, wherein the outer face (13) comprises openings for engaging splines.

31. A method of storing a rotary valve, the method comprising:

a. placing a rotary valve according to any one of claims 20 to 30 into a storage vessel; and

b. the rotary valve is stored for a period of time.

32. The method of claim 31, wherein storing the rotary valve comprises maintaining the rotary valve in a storage position in which the sealing pad is spaced apart from at least one of the rotor and the stator.

33. A rotary valve, the rotary valve comprising:

a. a rotor (10), the rotor (10) having an axis of rotation (16), an outer face (13) and a rotor valve face (12) opposite the outer face (13), and a pair of apertures (41, 42) through the rotor valve face (12), wherein the pair of apertures (41, 42) through the rotor valve face (12) are respectively an inlet and an outlet of a flow passage (40) containing a porous solid support (45);

b. a stator (50), the stator (50) having a stator face (52), the stator face (52) having a plurality of stator ports (53) therein, each of the plurality of stator ports (53) in communication with a fluid passage (54);

c. a gasket (80), the gasket (80) being interposed between the stator face (52) and the rotor valve face (12), the gasket (80) having an inner gasket sealing face (81 i) and an outer gasket sealing face (81 o) and a pair of gasket holes (83), the pair of gasket holes (83) being aligned with the pair of holes (41, 42), and

d. a retaining element (90), the retaining element (90) biasing the rotor and the stator toward each other, placing the inner gasket sealing face (81 i) and outer gasket sealing face (81 o) in a fluid tight arrangement with the plurality of stator ports (53) in the stator face (52).

34. The rotary valve according to claim 33, wherein the plurality of stator ports (53) are arranged as a plurality of stator ports at a first radial spacing from the rotational axis (16) and a plurality of stator ports at a second radial spacing from the rotational axis (16), wherein fluid communication between one of the plurality of stator ports at the first radial spacing and one of the plurality of stator ports at the second radial spacing is provided by a fluidic connector (86) extending between the inner gasket sealing face (81 i) and the outer gasket sealing face (81 o).

35. Rotary valve according to claim 33, wherein the plurality of stator ports (53) are arranged as a plurality of stator ports positioned circumferentially around the rotation axis at a first radial spacing from the rotation axis (16) and a plurality of stator ports positioned circumferentially around the rotation axis (16) at a second radial spacing from the rotation axis (16), wherein the fluid communication between one of the plurality of stator ports at the first radial spacing and one or more of the plurality of stator ports at the second radial spacing is provided by a fluidic selector (87) extending between the inner and outer gasket sealing faces (81 i, 81 o) and along a portion of the outer gasket sealing face (81 o).

36. The rotary valve of claim 33, wherein the plurality of stator ports (53) are arranged as a plurality of stator ports positioned circumferentially about the axis of rotation at a first radial spacing from the axis of rotation (16), and the gasket (80) further includes a fluidic selector (87), the fluidic selector (87) extending between the inner and outer gasket sealing faces (81 i, 81 o) and along a portion of the outer gasket sealing face (81 o), wherein fluid communication is provided by the fluidic selector (87) between one of the plurality of stator ports at the first radial spacing and one or more of the plurality of stator ports at a different circumferential position at a second radial spacing from the axis of rotation and from the one of the plurality of stator ports at the first radial spacing.

37. The rotary valve according to claim 33, the gasket (80) further comprising a fluidic selector (87), the fluidic selector (87) extending between the inner gasket sealing surface (81 i) and the outer gasket sealing surface (81 o) and along a portion of the outer gasket sealing surface (81 o).

38. The rotary valve according to claim 33, the gasket (80) further comprising a fluidic connector (86), the fluidic connector (86) extending between the inner gasket sealing surface (81 i) and the outer gasket sealing surface (81 o).

39. The rotary valve of claim 33, the gasket further comprising a fluidic selector (87) and a fluidic connector (86), wherein in use each stator port (53) is in communication with one of the fluidic selector (87), the fluidic connector (86), the inner gasket sealing surface (81 i), the outer gasket sealing surface (81 o) or a gasket bore (83).

40. The rotary valve according to claim 33, the sealing gasket further comprising a fluidic connector (86), wherein in use each stator port (53) is in communication with one of the fluidic connector (86), the inner sealing gasket sealing surface (81 i), the outer sealing gasket sealing surface (81 o) or a sealing gasket hole (83).

41. Rotary valve according to claim 33, wherein the pair of holes (41, 42) through the rotor valve face (12) is a first pair of holes communicating with a first flow path having a first solid carrier chamber and the other pair of holes through the rotor valve face (12) communicates with a second flow path having a second solid carrier chamber, wherein the first and second solid carrier chambers contain a porous solid carrier (45).

42. The rotary valve according to claim 41, wherein the porous solid support (45) is a polymer.

43. The rotary valve according to claim 41, wherein the porous solid support (45) is selected from the group consisting of: silica, diatomaceous earth, ceramics, metal oxides, porous glass, carbohydrate polymers, chitin, zeolites, polyvinyl ethers, polyethylene, polypropylene, polystyrene, nylon, polyacrylates, polymethacrylates, polyacrylamides, and polymaleic anhydride, and any combination thereof.

44. The rotary valve according to claim 41, wherein the porous solid support (45) is a membrane.

45. The rotary valve according to claim 41, wherein the porous solid support (45) is a hollow fiber.

46. The rotary valve according to claim 41, wherein the porous solid support (45) is a fiber.

47. A rotary valve, the rotary valve comprising:

a. a rotor (10), the rotor (10) comprising an outer face (13) and a rotor valve face (12) opposite the outer face (13), and a pair of apertures (41, 42) through the rotor valve face (12);

b. a stator (50), the stator (50) having a stator face (52), the stator face (52) having a plurality of stator ports (53) therein, each of the plurality of stator ports (53) in communication with a fluid passage (54); and

c. a seal (80), the seal (80) interposed between the stator face (52) and the rotor valve face (12), wherein a pair of seal holes (83) in the seal align with the pair of holes (41, 42), wherein the seal is spaced from the stator face (52) in a storage state and is held in fluid tight relationship with the stator face by a retaining element (90) when released from the storage state.

48. The rotary valve of claim 47, further comprising a retaining ring surrounding the rotor and coupled to the stator, the retaining ring having a pair of arcuate shapes along a surface adjacent the rotor, and the rotor having a pair of complementary arcuate shapes corresponding to the pair of arcuate shapes in the retaining ring, wherein engagement of the pair of arcuate shapes with the pair of complementary arcuate shapes retains the rotary valve in the storage state.

49. The rotary valve of claim 48, wherein the rotary valve is released from the storage state by relative movement between the rotor and the retaining ring sufficient to disengage the pair of arcuate shapes along the surface adjacent the rotor from the pair of complementary arcuate shapes on the rotor.

50. The rotary valve of claim 47, further comprising a retaining ring surrounding the rotor and coupled to the stator, the retaining ring having a plurality of grooves surrounding a portion of the retaining ring adjacent the rotor, and the rotor having a plurality of complementary shapes that matingly correspond with the plurality of grooves in the retaining ring, wherein engagement of the plurality of grooves with the plurality of complementary shapes of the rotor retains the rotary valve in the storage state.

51. The rotary valve of claim 50, wherein the rotary valve is released from the storage state by relative movement between the rotor and the retaining ring sufficient to disengage the plurality of grooves around a portion of the retaining ring from the matching corresponding plurality of complementary shapes on the rotor.

52. The rotary valve of claim 47, further comprising a spacer disposed along a gasket sealing surface, wherein the spacer maintains a gap between the gasket sealing surface and the stator surface and maintains the rotary valve in the storage state.

53. The rotary valve of claim 52, wherein the rotary valve is released from the storage state by relative movement between the rotor and the stator sufficient to displace the spacer to allow engagement between the gasket sealing surface and the stator surface.

54. The rotary valve of claim 47, further comprising a clip engaged with the rotary valve to maintain a gap between a gasket sealing face and the stator face and to maintain the rotary valve in the storage state.

55. The rotary valve of claim 54, wherein when the clip is removed, the rotary valve is released from the storage state, thereby allowing the retaining element to move the sealing pad into fluid-tight relationship with the stator face.

56. A rotary valve, the rotary valve comprising:

a rotor (10), the rotor (10) having an axis of rotation (16), a rotor valve face (12), an outer face (13) opposite the rotor valve face;

a stator (50), the stator (50) having a stator valve face positioned opposite the rotor valve face; and

a retaining element (90), the retaining element (90) biasing the rotor and the stator towards each other, the retaining element (90) comprising a retaining ring (91) and a biasing element (96), wherein the rotary valve is maintained in a storage state when the threaded portion of the retaining ring engages the threaded portion of the rotor.

57. The rotary valve of claim 56, wherein relative movement between the rotor and the stator creates a fluid-tight arrangement between the rotor valve face and the stator valve face.

58. The rotary valve of claim 57, wherein the relative motion between the rotor and the stator is a rotation of the rotor to move the rotor along the threaded portion of the retaining ring.

59. The rotary valve of claim 56, wherein the rotation of the rotor to disengage the rotary valve from the storage state is less than one revolution, half a revolution, one quarter revolution, or one eighth revolution.

60. The rotary valve of claim 56, further comprising a sealing pad disposed between the rotor valve face and the stator valve face, wherein the sealing pad does not form a fluid tight seal with the stator valve face when the rotary valve is in the storage state.

61. The rotary valve of claim 60, wherein relative movement between the rotor and the stator creates a fluid tight arrangement between the sealing gasket, the rotor valve face, and the stator valve face.

62. The rotary valve of claim 60, wherein the relative motion between the rotor and the stator is a rotation of the rotor to move the rotor along the threaded portion of the retaining ring.

63. The rotary valve according to claim 60, wherein the rotation of the rotor transitioning the rotary valve from the storage state is less than one revolution, is a half revolution, is a quarter revolution or an eighth revolution.

64. A rotary valve according to any one of claims 56 to 63, wherein the threaded portion of the rotor is separated from any other threaded portion of the rotary valve when the rotor is out of the storage state and a sealed relationship is formed between the rotor and the stator.

65. A rotary valve (00), the rotary valve (00) comprising:

b. a rotor (10), the rotor (10) operably connected to the stator and comprising an axis of rotation (16), a rotor valve face (12) and a flow passage (40) having an inlet (41) and an outlet (42) at the rotor valve face, a solid support chamber in communication with the inlet (41) and the outlet (42), a porous solid support (45) located within the solid support chamber (46); and

66. The rotary valve of claim 65, the solid support chamber having a bottom and a sidewall and at least one flow path spacer along the bottom.

67. The rotary valve of claim 66, wherein the at least one flow path spacer is raised above the bottom of the solid support chamber.

68. The rotary valve of claim 66, wherein the at least one flow passage spacer is recessed into the bottom of the solid support chamber.

69. The rotary valve of claim 66, wherein the at least one flow path spacer is spaced apart from the outlet (42) and the sidewall of the solid support chamber.

70. The rotary valve according to claim 66, wherein the at least one flow path spacer is directly adjacent to the outlet (42).

71. The rotary valve according to claim 66, wherein the at least one flow passage spacer has an arcuate shape corresponding to a curvature of the sidewall of the solid support chamber.

72. The rotary valve according to claim 66, wherein the at least one flow path spacer extends from the outlet (42) towards the sidewall.

73. The rotary valve according to any of claims 66-72, wherein the bottom of the solid support chamber is flat.

74. A rotary valve according to any of claims 66-72, wherein the bottom of the solid support chamber is inclined from the side wall of the solid support chamber towards the outlet (42).

75. The rotary valve of any of claims 65-72, wherein the porous solid support is a polymer.

76. The rotary valve according to any one of claims 65-72, wherein the porous solid support is selected from the group consisting of: silica, diatomaceous earth, ceramics, metal oxides, porous glass, carbohydrate polymers, chitin, zeolites, polyvinyl ethers, polyethylene, polypropylene, polystyrene, nylon, polyacrylates, polymethacrylates, polyacrylamides, and polymaleic anhydride, and any combination thereof.

77. The rotary valve of any of claims 65-72, wherein the porous solid support is a membrane.

78. The rotary valve of any one of claims 65-72, wherein the porous solid support is a hollow fiber.

79. The rotary valve according to any of the claims 65-72, wherein the porous solid support is a fiber.

80. The rotary valve of any of claims 65-72, wherein the rotary valve is configured to remain in an initial stowed state without a fluid tight seal between the rotor and the stator prior to the retaining element biasing the rotor and the stator into a fluid tight seal arrangement.

81. The rotary valve according to any one of claims 1, 20, 33, 47, 56 or 65, having a rotor cover (30) covering each solid support chamber (46) in the rotor (10).

82. The rotary valve according to any one of claims 1, 20, 33, 47, 56, or 65, comprising a rotor cover (30) covering the entire rotor outer face (13), wherein uncovered portions correspond to the one or more openings (17).

83. The rotary valve according to any one of claims 1, 33, or 65, comprising a rotor cover (30), the rotor cover (30) having a bottom surface (34), the bottom surface (34) being positioned to seal each solid support chamber (46) sufficient to complete a portion of the flow path (40).

84. A method of fluid treatment using a rotary valve, comprising:

rotating the rotary valve about an axis of rotation (16) to align a seal inlet (84) and a seal outlet (85) of a seal (80) with an inlet (41) and an outlet (42), respectively, of a flow passage (40) having a porous solid support (45) within a rotor (10) and to align the seal inlet (84) and the seal outlet (85) with a first pair of stator ports in a stator valve face (52); and

sealing a second pair of stator ports in the stator valve face (52) with a portion of the gasket (80).

85. The method of fluid treatment according to claim 84, further comprising:

rotating the rotary valve about the axis of rotation (16) to align the first pair of stator ports in the stator valve face (52) with fluidic connectors (86) formed in the gasket (80);

or rotating the rotary valve about the axis of rotation (16) to align the second pair of stator ports in the stator valve face (52) with the fluidic connector (86) formed in the gasket (80);

or rotating the rotary valve about the axis of rotation (16) to align at least one stator port of the first pair of stator ports in the stator valve face (52) with at least one stator port of the second pair of stator ports using a fluidic selector (87) formed in the sealing gasket (80);

or rotating the rotary valve about the axis of rotation (16) to align at least one stator port of the first pair of stator ports in the stator valve face (52) with at least one stator port of a third pair of stator ports using a fluidic selector (87) formed in the gasket (80).

86. The method of fluid treatment according to claim 84, further comprising:

rotating the rotary valve about the axis of rotation (16) for flowing fluid through the first pair of stator ports or the second pair of stator ports before flowing fluid through the flow passage (40).

87. The method of fluid treatment of claim 85, further comprising:

rotating the rotary valve about the axis of rotation (16) for flowing fluid through the fluidic connector (86) formed in the seal (80) or through the fluidic selector (87) formed in the seal (80) before flowing fluid through the flow passage (40).

88. The method of fluid treatment of claim 84, further comprising:

rotating the rotary valve about the axis of rotation (16) to flow fluid through the first pair of stator ports or the second pair of stator ports after the fluid flows through the flow passage (40).

89. The method of fluid treatment of claim 85, further comprising:

rotating the rotary valve about the axis of rotation (16) for flowing fluid through the fluidic connector (86) formed in the seal (80) or through the fluidic selector (87) formed in the seal (80) after flowing fluid through the flow passage (40).

90. The method of fluid treatment according to claim 84, further comprising:

after the fluid flows through the flow passage (40), the fluid is caused to flow through the first fluid channel or the second fluid channel.

91. The method of fluid treatment according to claim 84, further comprising:

flowing fluid through the first fluid channel or the second fluid channel before flowing through the flow passage (40).

92. The method of fluid treatment of claim 85, further comprising:

after positioning the rotary valve to flow fluid through the flow passage (40), the rotary valve is positioned to flow fluid to a fluid channel (54) through the fluidic connector (86) formed in the gasket (80) or to a fluid channel (54) through the fluidic selector (87) formed in the gasket (80).

93. The method of fluid treatment of claim 85, further comprising:

positioning the rotary valve to flow fluid to a fluid channel (54) through the fluidic connector (86) formed in the seal (80) or through the fluidic selector (87) formed in the seal (80); and

a portion of the fluid is stored in a storage chamber in communication with the fluid passage (54).

94. The method of fluid treatment of claim 85, further comprising:

a portion of the fluid is mixed with lysis buffer.

95. The method of fluid treatment of claim 94, further comprising:

positioning the rotary valve to flow fluid from the mixing step to the flow path (40) through the fluidic connector (86) formed in the gasket (80) or through the fluidic selector (87) formed in the gasket (80).

96. The method of fluid treatment of claim 94, further comprising:

the rotary valve is positioned to flow fluid from the mixing step through the porous solid support (45).

97. The method of fluid treatment of claim 85, further comprising:

positioning the rotary valve to flow fluid through the fluidic connector (86) formed in the gasket (80) or through the fluidic selector (87) formed in the gasket (80) to a waste chamber.

98. The method of fluid treatment of claim 85, further comprising:

positioning the rotary valve to align a pneumatic source with the fluidic connector (86) formed in the seal (80) or with the fluidic selector (87) formed in the seal (80).

99. The method of fluid treatment of claim 84, further comprising:

positioning the rotary valve to align a pneumatic source with the flow passage (40).

100. The method of fluid treatment according to claim 84, further comprising:

positioning the rotary valve to flow water through the flow passage (40).

101. The method of fluid treatment of claim 85, further comprising:

positioning the rotary valve to flow water through the fluidic connector (86) formed in the seal (80) or through the fluidic selector (87) formed in the seal (80).

102. The method of fluid treatment according to claim 84, further comprising:

the rotary valve is positioned to flow positive samples to the positive metering pathway and negative samples to the negative pooling pathway.

103. The method of fluid treatment according to claim 84, further comprising entering a first fluid channel via said first pair of stator ports in said stator valve face (52) or entering a second fluid channel via said second pair of stator ports.

104. The method of fluid treatment of claim 85, further comprising accessing a third fluid passage via said third pair of stator ports in said stator valve face (52).

105. The method of fluid treatment according to any of claims 84-86, 88, 90, 91, 95, 96, 99, 100, 102, 103, or 104, further comprising positioning the gasket inlet (84) and the gasket outlet (85) against a portion of the stator valve face (52) without a stator port (53).

106. The method of fluid treatment according to claim 84, further comprising:

prior to the rotating step, moving the rotary valve from a storage state to a ready-to-use state.

107. The method of fluid treatment according to claim 106, said step of moving said rotary valve from a storage state to a ready to use state further comprising:

moving the gasket (80) into contact with the stator valve face (52).

108. The method of fluid treatment of claim 106, the step of moving the rotary valve from a storage state to a ready to use state further comprising:

deflecting a displaceable spacer (60) maintaining a gap between the rotor and the stator; and

moving the gasket (80) into fluid tight relationship with the stator valve face (52).

109. The method of fluid treatment of claim 106, the step of moving the rotary valve from a storage state to a ready to use state further comprising:

rotating the rotor relative to a threaded retaining ring; and

moving the seal (80) into contact with the stator valve face (52).

110. The method of fluid treatment according to claim 106, said step of moving said rotary valve from a storage state to a ready to use state further comprising:

moving the rotor to displace a sacrificial edge (180) of the seal (80); and

moving the gasket (80) into contact with the stator valve face (52).